[e-farmacos] Reunion en Botswana para desacreditar los genericos

[e-farmacos <e-farmacos-owner@healthnet.org>]

[Hemos recibido la siguiente peticion de adhesion para ayudar a defender el proyecto de precualificacion y al Departamento EDM de la OMS. Se trata de expresar la preocupacion por los esfuerzos que realiza la administracion Bush para bloquear el uso de medicamentos genericos para VIH/SIDA a precios asequibles en los programas financiados por los Estados Unidos. En caso de estar de acuerdo con los terminos expresados en el documento, por favor, enviad vuestra adhesion a: pdavis@healthgap.org  Gracias!, AF]

22 March 2004:
URGENT SIGN-ON letter re:
US Meeting in Botswana to discredit generics

Please help to defend the WHO EDM and Prequalification Project. This
international sign-on letter for NGOs needs to be circulated widely.
Organizational endorsements to pdavis@healthgap.org by Thursday, March 26.

Our hope is that Ministers of Health and NDRA officials will also be
publicly opposing efforts to undermine WHO's prequalification standards and the use of prequalified generic medicines.

Sharonann Lynch
Health GAP

----------------------------------------------------
INTERNATIONAL NGO SIGN-ON LETTER

26 March 2004

Ambassador Randall Tobias
Global AIDS Coordinator
U.S. Department of State
Washington, D.C.

Dear Ambassador Randall Tobias,

We, the undersigned organizations, are writing to express our serious
concerns about efforts by the Bush administration and by your office
to block the use of affordable generic HIV/AIDS medicines in U.S.-financed programs in poor countries. In order to mount a rapid and successful response to the growing AIDS pandemic, we call upon you to ensure that programs use the most affordable medicines available, and accept the current drug quality standards of World Health Organization's drug prequalification program. 

We are particularly concerned about the U.S.-initiated "Conference on
Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical
Issues related to Safety, Quality, and Effectiveness," 29-30 March
2004 in Gaborone, Botswana. This meeting needlessly casts doubt upon
the clinically proven quality of generic AIDS medicines, and disregards the WHO's internationally recognized Drug Prequalification Program. The meeting is intended to create a justification to use only expensive, less effective branded drugs in international assistance programs, and will be used by the US to justify its efforts to use bilateral assistance programs to lock generics out of developing countries. Of particular concern is your attempts to discredit the use of urgently needed fixed- dose combinations (FDCs)
of antiretroviral AIDS medications.

Single-pill combinations promote adherence, decrease the risk of resistance, and facilitate stock and procurement management, and are widely recognized as a core element in efforts to scale up ARV treatment in developing countries. FDCs are strongly preferred over blister packs and other multi-pill regimens. In addition to ease of use and other advantages, FDCs, which are taken in the form of one pill twice a day, are also by far the least expensive option: today, triple FDCs from generic manufacturers are available for as little as $140 per person per year. The same combination from brand-name companies costs a minimum of $562 per person per year and must be taken in the form of six pills a day. Forcing people with HIV/AIDS to accept higher pill burdens, wasting limited taxpayer resources on brand name products, and, most importantly, using scarce resources to treat one person when the same amount of money could treat four is unacceptable.

If the ambitious goals of the President´s Emergency Plan for AIDS Relief (PEPFAR), and the WHO's "3 by 5" initiative are to be met, triple combination FDCs pre-qualified by WHO must be made widely available.

FDCs are recommended in WHO treatment guidelines, and several generic FDCs have been certified by WHO as meeting stringent international standards for drug quality, safety and efficacy through its Prequalification Project. The WHO's standards for prequalification are supported by UNICEF, the World Bank, the Global Fund to Fight AIDS. TB, and Malaria, Columbia University's MTCT-Plus program, many national governments in developing countries, international humanitarian organizations such as Médecins Sans Frontières (MSF), and other programs with experience treating people living with HIV.
Clinicians in resource poor settings are already using triple combination generics with tens of thousands of patients, with efficacy and adherence rates equal-to-or-better than treatment success and adherence rates in the United States. 

Rather than disregarding the drug procurement policies of developing nations to creating expensive new barriers that benefit US drug companies, your office should accept the WHO's internationally recognized drug quality standards and promote access to affordable medications. We object to any and all efforts by the Bush Administration and your office to block the use of WHO prequalified generic medications, and any efforts to discredit the standards of WHO's prequalification project that would impose new barriers to generics entering the global market.

Sincerely,



--
Sharonann Lynch
salynch@healthgap.org
Health GAP (Global Access Project)
Tel  +1 212 674-9598
Mob +1 646 645-5225
http://www.healthgap.org