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US Seeks Further Restrictions on Generic
Medicines for Developing Countries
http://www.doctorswithoutborders.org/pr/2003/08-25-2003.shtml
25 August 2003, Geneva - Doctors
Without Borders/Médecins Sans Frontières (MSF), Oxfam,
Health Action International (HAI), Third World Network (TWN)
and the Consumer Project on Technology (CPTech)— NGOs long
involved in the process over “Paragraph 6” — have
acquired new information indicating that the US seeks further
restrictions on exports of generic medicines to developing
countries. They fear that the recent talks at the WTO TRIPS
Council may result in further threats to access to medicines
in poor countries.
The NGOs have learned that, in a small group
of five negotiating countries, the US has been seeking further
provisions on a deal nearly agreed to in 2002, known as the
“December 16” or “Motta text.” Since 2001, the WTO
TRIPS Council has been trying to find a solution to what is
known as the Paragraph 6 problem: countries without drug
production capacity will not be able to make meaningful use of
compulsory licensing because of TRIPS restrictions on exports
of generics.
According to MSF’s Ellen ‘t Hoen, “The
proposed deal poses so many hurdles and hoops to jump through,
that we are really worried it may not work at all. By
continually demanding more restrictions, the US seems to be
pushing for a watertight system so that no generic drugs ever
get through to the patients in developing countries who
desperately need them.”
On top of the Motta text, US demands
apparently include:
Restricting
the solution to “humanitarian use,” a vague clause that
may disqualify normal generic production;
An
“opt-out” clause, that will further hinder the economic
viability of the solution;
Heavier
burdens on suppliers to change the packaging of products made
under this system; and
A
“review mechanism,” to monitor usage of the system and
diversion of generics back into wealthy markets; this is a
redundant layer of bureaucracy that can easily be manipulated
to pressure countries out of the system.
Taken together, the effects of these
provisions would be to discourage countries from using the
system at all, and to heavily restrict generic production. The
Motta text is already extremely cumbersome and does not
provide an economic incentive to export generics. It seems
that the US is pushing for additional limitations to the Motta
text, which would be included in an accompanying
“Chairman’s Text”.
Both the WHO and intellectual property
experts have recommended a much simpler, workable, and
economically viable solution: allowing generic production for
export as a limited exception to a patent right. This is the
solution the NGOs also favor.
“We recommend the WTO start with a clean
slate,” said Michael Bailey of Oxfam. “WTO Members should
take the time to find a real solution. Surely it is more
important to get medicines to the most vulnerable populations,
than simply to have a deal cut by Cancun.”
Current negotiations are occurring in
talks between the TRIPS Council Chair and just five countries:
the United States, Brazil, India, South Africa, and Kenya
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