Colombian NGOs File Compulsory License Request on Lopinavir/Ritonavir (Kaletra)

Peter Maybarduke, Guest Blogger
Essential Action
www.essentialinformation.org/access
July 16, 2008

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 the email address below, or contact the Mesa de Organizaciones con trabajo en VIH/SIDA and RECOLVIH at 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
peter.maybarduk@essentialinformation.org

-------

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.
Coordinador
Mesa de Organizaciónes RECOLVIH con trabajo en VIH/Sida

JAVIER LEONARDO VARON
Coordinador
Mesa de Organizaciónes RECOLVIH con trabajo en VIH/Sida

FRANCISCO ROSSI
Director
Fundación IFARMA-AIS Fundación Misión Salud

GERMÁN HOLGUÍN ZAMORANO
Director
Fundación IFARMA-AIS Fundación Misión Salud

 

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