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[e-drug] Colombian NGOs files compulsory license request on lopinavir/ritonavir (Kaletra)

E-DRUG: Colombian NGOs files compulsory license request on lopinavir/ritonavir 
(Kaletra)
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Colleagues,

Yesterday, Colombian NGOs filed requests for an open compulsory license 
on AIDS drug lopinavir/ritonavir (Abbott's Kaletra) with the Colombian 
government. The NGOs delivered request letters to the Superintendencia 
de Industria y Comercio, which houses the patent office, as well as to 
the office of the President of the Republic. Additionally, the NGOs 
delivered a letter to the Ministry of Health, requesting a declaration 
of public interest in access to lopinavir/ritonavir.

The compulsory license request comes three months after Colombian civil 
society requested an open license for lopinavir/ritonavir directly from 
Kaletra manufacturer and patent holder Abbott Laboratories. To date, 
Abbott has not responded to the groups' request.

Below, please find my translation of the letter Colombian NGOs delivered 
to the Superintendencia de Industria y Comercio yesterday in Bogotá (all 
translation errors are mine).

The letters were accompanied by appendices and a technical document, 
approximately twenty pages in length, analyzing potential cost savings, 
legislation, drug quality, license procedures, human rights and AIDS 
treatment accords, lopinavir/ritonavir indications, and the medicine's 
importance to national programs.

For more information, or for formatted copies of the letters and 
technical document, please contact me at this address, or contact the 
Mesa de Organizaciones con trabajo en VIH/SIDA and RECOLVIH at 
licencia.obligatoria.colombia@gmail.com 
<mailto:licencia.obligatoria.colombia@gmail.com>. Scanned copies of the 
signed letters are available in PDF, as well.

A letter asking for organizational signatures in support of the license 
request will follow soon.

Thank you,

Peter Maybarduk
Essential Action
e-mail: peter.maybarduk@essentialinformation.org

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Bogotá, D.C. Julio 15 de 2008

Dr. *GUSTAVO VALBUENA QUIÑONES*

Superintendent of Industry and Commerce
In reference to: Petition in general interest. Request for an open 
license for lopinavir / ritonavir (Kaletra) for reasons of public interest.
Dear Superintendent,
The Working Group of HIV/AIDS Organizations (Mesa de Organizaciones con 
trabajo en VIH/SIDA), Colombian Network of People Living with HIV 
(RECOLVIH), Foundation IFARMA AIS (Health Action International/HAI), and 
Foundation Health Mission (Fundación Misión Salud), request:
The grant of an open compulsory license for lopinavir/ritonavir 
(Kaletra) for reasons of public interest.
The Working Group of HIV/AIDS Organizations represents the Colombian 
League of the fight against AIDS (la Liga Colombiana de lucha contra el 
sida), la Fundación Hope Worldwide, Corporación Milagroz, Fundación 
Henry Ardila, Fundación Tejedores de vida, Fundación Huellas de Arte, 
ASIVIDA, ASVIHDA, Fundación Voluntarios del Mundo, Fundación Procrear, 
Proyecto Girasol, Fundación Arenosa Vive y Corporación Viviendo con 
Dignidad, thirteen institutions dedicated to work in HIV/AIDS, in Bogotá 
and other regions of the country;
The Colombian Network of People Living with HIV, the Foundation IFARMA, 
Colombian representative of Health Action International, and the 
Foundation Health Misión, are all organizations of Colombian civil 
society, not for profit, and without interests apart from the public good.
The license would authorize any person, business or company to use any 
patented invention owned in the Republic of Colombia by Abbott 
Laboratories and its affiliates, including patents held in common by 
Abbott Laboratories and other entities, to produce, manufacture, import, 
export, distribute, offer in liquidation, sell, purchase or use the 
medicine known commercially as Kaletra (lopinavir/ritonavir), in 
accordance with the authority established under Article 65 of Andean 
Community Decision 486, and Resolution 17585/01 of the Superintendency 
of Industry and Commerce.
The request is founded in the following:
Of Fact:
The Public Interest
Lopinavir / ritonavir is a key medicine in HIV/AIDS treatment. 
Calculations based on data from a study by the Ministry of Social 
Protection and U.N.AIDS indicate that in 2005, nearly 1,275 people 
living with HIV/AIDS in Colombia were taking Kaletra. A survey of health 
organizations reported that Kaletra use grew from 3 million units in 
2004 to more than 6 million units in 2006. That is to say, Kaletra 
consumption doubled in a period of just two years.
The price of medicines in the Colombian market constitutes a barrier to 
access. In the case of Kaletra, patents have permitted Abbott to 
maintain prices higher than a competitive market would bear. Considering 
only the lower prices offered to public institutions, Kaletra's current 
Colombia price is about $1,683USD per patient, per year. (Prices for 
private institutions are higher, and reach $4,449 per patient per year.) 
Multiplying the public sector price by the number of patients, Kaletra 
currently costs Colombia's public health system about $2,144,633 per 
year. Meanwhile, high-quality generic versions of lopinavir/ritonavir 
are available in many countries with prices under $800. Through a recent 
agreement between the Clinton Foundation and generics firms, prices can 
reach $550 per patient, per year, 67.3% cheaper than Abbott's product in 
Colombia. A license authorizing generic competition would enable a 
significant and immediate change in the cost of this medicine in Colombia.
Studies by organizations signing this letter, and studies by the Office 
for the Defense of the Public, show that the high price of Kaletra 
constitutes a barrier to access and an assault on patients' rights, in 
two ways. First, given limited state resources, high prices set back the 
expansion of coverage. The promise of universal coverage cannot be 
realized in practice. Second, patients receiving high-cost medicines 
through state programs or insurance agreements endure long lines, legal 
forms, stigma and discrimination, both subtle and expressly stated. More 
than a few patients abandon treatment to avoid these problems, putting 
their own lives at risk.
A compulsory license for lopinavir/ritonavir in Colombia would allow the 
state to obtain and offer imported generics, as well as permit the local 
production of lopinavir/ritonavir. The result could be greater product 
availability for patients, robust competition, and savings for the 
state, which could be directed to other public needs.
In recent years, Brazil, Indonesia, Malaysia, Mozambique, South Africa, 
Zambia Eritrea and Thailand have issued compulsory licenses to promote 
access to medicines. Indeed, governments of many countries, including 
the United States, make use of compulsory licenses in a wide variety of 
circumstances.
A comparative analysis of costs and coverage in the Andean region makes 
clear that Colombia finds itself at a disadvantage. (See Technical 
Document, attached, Chapter 5.) Lack of access to ARVs for people living 
with HIV/AIDS means a rise in morbidity and mortality. This, in addition 
to making vulnerable the Right to life and to health, increases costs to 
the state of caring for those who fall ill.
Of Right:
Under Article 65 of Andean Community Decision 486, and Article 31 of the 
WTO TRIPS agreement, Colombia has the right to grant compulsory licenses 
on public interest grounds, and authorize generic competition with 
patented pharmaceuticals. Under this authority, the generics may be 
produced locally or imported; the only condition is that they pay a 
reasonable remuneration to the patent holder. This license request 
suggests license terms following international standards (attached).
Under TRIPS Article 31(b), before issuing a compulsory license, proposed 
users should seek to obtain voluntary licenses under reasonable terms, 
until a reasonable period has passed (normally three months or less). On 
April 7, 2008, the Working Group of HIV/AIDS Organizations and RECOLVIH 
filed an open license request for lopinavir/ritonavir at the main Bogotá 
offices of Abbott Laboratories. To date, the Working Group and RECOLVIH 
have received no response. Hence, the present request letter for a 
compulsory license.
The right to life, the right to real and effective equality and the 
right to access to health services are fundamental and social 
constitutional rights. Further, and also by constitutional mandate, 
property has a social function. Finally, in accordance with principles 
of economy and transparency, state resources must be used optimally. 
Reducing costs and increasing coverage are public interest priorities.
Supporting Documents and Appendices
The attached technical document and appendices provide details about 
lopinavir/ritonavir and its uses, an analysis of the legislation, 
suggested license terms, cost studies, quality assurances, and an 
assessment of the effects of compulsory licenses, completed by national 
and international organizations (Essential Action, IFARMA, Health Action 
International, Mission Health, among others).
This request is filed under the Right to Petition in General Interest, 
and accordingly we ask it be given the timely and serious consideration 
available under the terms of that law.
Thank you for your attention to this request. Please do not hesitate to 
contact us for any necessary clarification. We respectfully await your 
prompt and favorable response.
Cordially,

*JORGE PACHECO C.** ** ** **JAVIER LEONARDO VARON*

      Coordinador                          Coordinador 

Mesa de Organizaciónes    RECOLVIH   

con trabajo en VIH/Sida

*FRANCISCO ROSSI** ** ** **GERMÁN HOLGUÍN ZAMORANO*

      Director     Director

Fundación IFARMA-AIS        Fundación Misión Salud

La presente solicitud consta de cuatro folios y un documento técnico anexo.

*NOTIFICACIONES: *

Cra. 18 Nº 36-63 Of. 201         Tel 3384991     

Avenida 32 Nº 14-46   Tel 2454757

* ** ** *

* *

* *

*E-mails:*

licencia.obligatoria.colombia@gmail.com 
<mailto:licencia.obligatoria.colombia@gmail.com>

recolvih@yahoo.com <mailto:recolvih@yahoo.com>  

mesaongsvihsida@gmail.com <mailto:mesaongsvihsida@gmail.com>

francisco*_*rossi@hotmail.com <mailto:francisco_rossi@hotmail.com>

misionsalud@yahoo.com <mailto:misionsalud@yahoo.com>

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