[Random-bits] USTR responds to CPTech query on "opt-out" of WTO Mechanism to import generic medicines

[James Love]

The following is a February 9, 2006 letter, written by the Victoria
Espinel of the USTR, regarding our October 14, 2005 letter (http://
www.cptech.org/ip/birdflu/ustr-birdflu.html) that was sent to USTR
head Rob Portman, regarding the US decision to "opt-out" of the WTO
mechanism to import generic medicines manufactured under a compulsory
license in a foreign country.  The United States decided that it
would never use this mechanism, *even* in cases involving national
emergencies.    There have already been two cases since 2001 when the
United States was caught without sufficient domestic supplies of a
medicine that was needed for stockpiles that would protect US
residents from potential public health emergencies (ciprofloxcin in
2001, and Tamiflu in 2005-6).  The USTR does not acknowledge this
fact, and maintains the position that (1) the US has sufficient
domestic capacity to address such access issues, and (2) it is
"helping" developing countries by "opting out" of the WTO mechanism
as an importer.   In our view, USTR is wrong on both counts.  As
noted, there has been dramatic evidence of shortages of important
medicines twice since 2001 (US Tamiflu stockpiles are still woefully
small given WHO guidelines), exposing US residents unnecessarily to
risks.   The US "opt-out" is also part of a larger strategy to
marginalize developing countries to *not* use compulsory licensing
and to reduce the market and economies of scale for developing
country generic suppliers.  The opt-out is not at all designed to
promote access to generic medicines in developing countries.   It is
not designed to protect US residents.  It is designed to protect
Pfizer, Roche, and other big pharma companies from creditable threats
that compulsory license will be used, in any circumstances.

  Jamie

Below is the USTR letter:


http://www.cptech.org/ip/birdflu/ustr-birdflu.html

http://www.cptech.org/ip/health/tamiflu/ustr02092006.pdf

EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
Washington, DC 20508

February 9, 2006

Mr. James Love
Consumer Project on Technology
1621 Connecticut Avenue, N.W.
Suite 500
Washington, D.C. 20009

Dear Mr. Love:

Thank you for your letter concerning the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) and the TRIPS public
health solution (TRIPS/health solution).

The TRIPS/health solution was an extraordinary measure, intended to
assist countries that lack the capacity to manufacture drugs. The
solution permits countries to override patent rights when necessary
to export life-saving drugs to developing countries that face public
health crises, but cannot produce drugs for themselves. The TRIPS/
health solution is a demonstration of how the World Trade
Organization (WTO) can work to address the needs of poor countries.

In the negotiations leading up to this solution, developed nations as
a whole recognized that it was not appropriate for us to import
pharmaceuticals under this system devised to assist poor countries
and agreed not to divert attention and resources away from countries
the system was intended to benefit. It was also apparent that the
United States was not a country that lacked manufacturing capacity,
given our robust pharmaceutical manufacturing base and the prevalence
of thriving U.S. innovative and generic pharmaceutical industries.

We supported the August 2003 TRIPS/health solution, under which the
developed world as a group, decided to "opt-out" and not risk
diverting resources from the countries in need. Additionally, we
supported the effort to make the TRIPS/health agreement reached in
August 2003 a permanent part of the WTO TRIPS Agreement.

On December 6, 2005, the WTO General Council agreed on an amendment
to make the August 2003 solution a permanent part of the WTO TRIPS
Agreement. Our efforts in working with Africa and other developing
countries were instrumental to reaching this agreement.

WTO Members now have until December 1, 2007 to accept the amendment.
The amendment will go into effect, for those Members that adopt it,
once two-thirds of the membership has adopted it. The August 2003
waiver will remain in place until- the amendment is in force.

On December 17, 2005, the United States became the first country to
formally notify the WTO that it had accepted the amendment.

Thank you for your letter, and I look forward to working with you.

Sincerely,

Victoria Espinel
Acting Assistant United States Trade Representative for Intellectual
Property



---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton