PHA-Exchange> URGENT turn around SIGN ON ltr: US Mtg to discredit generics

[Robert Weissman]

URGENT turn around SIGN-ON letter re:
US Meeting in Botswana to discredit generics

We need your help in sending a broad international message to the Botswana
meeting that the US cannot simply disregard internationally recognized
standards in order to create a new slush-fund for big pharma.

Please send organizational endorsements to pdavis at healthgap.org.

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Friends, we are absolutely in a crisis, and on the verge of substantially
losing simple, affordable generic combination AIDS drugs to the Bush
Administration and its efforts to get an international stamp of approval on
new policies that reject international quality standards, in favor of *only*
permitting medicines that have been approved by drug regulatory authorities
like the US FDA -- which could not legally approve AIDS generics for
sale in
the United States due to patent barriers!

As many of you know, the new US AIDS Czar is holding a meeting in Botswana
in a few days to create a policy document that will call into question the
proven quality of generic medications approved by the WHO's Drug
Prequalification Program. Other countries and NGOs will be present, and we
must put up a big fight.

This document will be used to pressure other nations to forgo generics. It
will also be used by the US as a policy floor for its own bilateral
programs. We are hearing from PEPFAR recipients and applicants that they are
being told flatly that no generics will be allowed. This is a bald attempt
to use foreign assistance to supercede WTO rules, national sovereignty AND
build a new drug quality barrier to Canadian drug reimports in the United
States -- a major issue this election year.

Once the US funds are substantially flowing, market access for generics will
quickly close down. Countries are unlikely to create multiple supply and
procurement chains for Global Fund grants or other national programs. If we
cannot derail agreement at this meeting, then we will have have lost the
most urgently needed tool to fight AIDS: easy to use and inexpensive single
pill combinations of lab-and-clinic proven quality.

We need your help in sending a broad international message to the Botswana
meeting that the US cannot simply disregard internationally recognized
standards in order to create a new slush-fund for big pharma.

Please send organizational endorsements to pdavis at healthgap.org.

Please send organizational endorsements ASAP - we want to send this letter
to Tobias by Thursday the 26th. Here's the letter:

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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.

Paul Davis
Health GAP (Global Access Project)
e: pdavis at healthgap.org
t: +1 215.833.4102 (mobile)
f: +1 215.474.4793
w: www.healthgap.org