Inside U.S. Trade
February 10, 2003
The Chairman of the WTO Council on Trade Related Aspects of
Intellectual Property Rights today (February 10) asked the World Trade
Organization General Council for another week to see if the U.S. and
other key players will sign on to an agreement giving countries the
right to source production of generic drugs abroad now that he has
proposed a compromise designed to limit use of these rights to dealing
with national emergencies.
TRIPS Council Chairman Eduardo Perez Motta late last week sought to
bring the U.S. on board by proposing to make a statement that countries
have "made it clear" that they see the more flexible patent rules under
an agreement "as being essentially designed to address national
emergencies or other circumstances of extreme urgency."
But so far, the U.S. has not said that the chairman's statement
sufficiently addresses its concern that an agreement not provide an
open-ended scope of diseases for use of the more flexible patent rules,
trade officials said. One of its chief concerns is the legal value of
such a chairman's statement in case there is a WTO dispute, sources
said.
Other key developing countries like Brazil and Kenya have also not
given their assent to the chairman's statement as a workable compromise.
However, other key African countries, including South Africa, have
signaled their willingness to accept the chairman's statement as the
basis for a deal, trade sources said, providing Motta with encouragement
that a deal could be struck that allows acceptance of the draft
agreement he proposed in December.
"My impression is that there is a widely shared desire to find a
solution as soon as possible and to be willing to look positively at
proposals aimed at providing the level of comfort necessary for the text
of 16 December to be acceptable to all. Indeed, I sense that a certain
momentum towards finding a solution has been generated in recent days
and I felt that it is important that advantage should be taken of this,"
Motta told the General Council today.
Motta, Mexico's WTO ambassador, said there have been "positive
reactions" to his recent ideas, and proposed continuing consultations in
Geneva and in capitals until the February 18 TRIPS Council meeting,
where he hoped to be able to report concrete results of these talks.
Motta's term as TRIPS council chairman ends at the February 18 meeting,
when he will be replaced by Singapore's WTO Ambassador Vanu Gopala
Menon.
Trade officials said they expected the access to medicines issue would
feature prominently among the development issues discussed at the
February 14-16 mini-ministerial of some 25 key WTO countries.
Although the language of Motta's statement moves toward limiting the
scope of a deal to national emergencies--the U.S. had pushed for
limiting the scope of diseases to health crises such as those resulting
from AIDS/HIV, malaria and tuberculosis--it remains unclear whether a
chairman's statement has the legal weight to define limits to use of the
more flexible patent rules, informed sources said. The U.S. is now
consulting with its industry on that question, sources said.
If a chairman's statement is precise and speaks to an ambiguity in the
text of an agreement, it can provide guidance for dispute settlement
panelists in interpreting that agreement, according to an informed
source.
The scope of diseases under the Dec. 16 text has room for conflicting
interpretations, since it refers generally to the "public health
problems" facing developing countries, but also uses AIDS/HIV, malaria
and tuberculosis as examples of such problems.
The chairman's statement pointing to national emergencies seems to be
an attempt to provide criteria for judging whether public health
problems fall within the scope of the agreement, the informed source
said. At the same time, it is far from clear that it provides any
legally binding limits to the deal, particularly when it is read in
conjunction with the Doha Declaration on the TRIPS Agreement and Public
Health
The chairman's statement also reconfirms countries' commitment to the
Doha Declaration on the TRIPS Agreement and Public Health, and that
agreement includes at least two statements that suggest the chairman's
statement would not have much effect in providing legally binding limits
on the scope of a deal.
For example, the Declaration states "Each member has the right to
determine what constitutes a national emergency or other circumstances
of extreme urgency, it being understood that public health crises,
including those relating to HIV/AIDS, tuberculosis, malaria and other
epidemics, can represent a national emergency or other circumstances of
extreme urgency."
In addition, the Declaration also affirms that "Each Member has the
right to grant compulsory licenses and the freedom to determine the
grounds upon which such licenses are granted."
Developing countries like Kenya are also asking Motta to clarify the
legal effect of his proposed statement.
"If it has no legal effect, then no problem," a Kenyan official said,
noting that his country remains opposed to an agreement that limits the
scope of a deal to national emergencies or situations of extreme
urgency. Kenya believes the agreement should be designed to give
countries that lack pharmaceutical manufacturing capacity the same
ability to use compulsory licenses as countries that can make their own
drugs.
In urging WTO members to reject the chairman's statement, Doctors
Without Borders, one of the key health groups in the debate, cautioned
countries not to take comfort that a chairman's statement has no legal
effect.
"Let no delegation be under the illusion that a Chair's note,
reflecting an agreement amongst all negotiating parties, can have no
legal effect. The Chair would not be making the note if it had no legal
effect and there are grave grounds to worry that under the Vienna
Convention [on the interpretation of treaties] it could be held to have
legal effect," Ellen 't Hoen wrote in a February 8 open letter to WTO
delegates. "As a result if the Motta text were used outside emergency
situations, the exporting member would open itself to dispute settlement
for breach of its obligations."
The Doctors Without Borders letter also argues that the limits set by
Motta's statement would prevent countries from purchasing generic drugs
in order to prevent a health emergency.
"It is unacceptable that a subset of developing countries may only
provide pharmaceutical care after a public health situation has gone out
of control," 't Hoen writes.
As an alternative, 't Hoen proposes that the Chairman's statement read
"Delegations have made it clear that they see the system that is being
established under this proposed solution as being designed to promote
access to effective treatments, to address public health problems
afflicting countries with insufficient or no manufacturing capacities in
the pharmaceutical sector. . ."
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