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[afro-nets] Impasse on TRIPS talks and the Health permanent solution

  • From: Claudio Schuftan <claudio@hcmc.netnam.vn>
  • Date: Fri, 18 Nov 2005 17:44:46 +0700

Impasse on TRIPS talks and the Health permanent solution
From: Third World Network

Impasse on TRIPS talks and the Health permanent solution

The World Trade Organisation was supposed to conclude a 'perma-
nent solution' to the problem facing countries that have no or
inadequate drug manufacturing capacity so that they can have ac-
cess to affordable medicines.

The impasse that has taken place in the recent negotiations
brings into focus the importance of the issue to the developing
countries in the light of the global avian flu threat and the
shortage of the anti viral drug to treat bird flu.

We include the background note by Sangeetha Shashikant and the
report on the talks by Martin Khor.

Please find below the latest news on negotiations taking place
in the World Trade Organization in Geneva on TRIPS (Trade Re-
lated Aspects of Intellectual Property Rights) and Public
Health, in relation to supply of medicines to countries with in-
sufficient or no manufacturing capacity.

Background Note:
[For those not familiar with Paragraph 6 Negotiations (also
known as the 30 August Decision)]

In November 2001, Trade Ministers in Doha agreed on a special
declaration recognizing the right of countries to take measures
to protect public health and promote access to medicines. This
Declaration came to be known as the Doha Declaration on the
TRIPS Agreement and Public Health (available at):

The Doha Declaration as it is commonly known, confirmed among
others the right of developing countries to use compulsory li-
censes (for purposes of import, manufacture and export of ge-
neric medicines without the consent of the patent holder but
subject to certain conditions), parallel importation etc.

It was expressly recognized by Paragraph 6 of the Doha Declara-
tion that a solution has to be found about supplying essential
medicines to countries with insufficient or no manufacturing ca-

This concern arose largely from the fact that once countries
that are major producers and exporters of generic products such
as India put in place laws that grant patents on pharmaceutical
products, these countries will face legal obstacles to produce
and export cheap generic copies of patented medicines. This will
be detrimental to the supply of medicines to countries with in-
sufficient or no manufacturing capacity.

India has beginning of this year allowed patents for pharmaceu-
ticals products.

Essentially if there a patent on a pharmaceutical product, pro-
duction for export can only take place under a compulsory li-
cense. However the TRIPS Agreement establishes that a compulsory
license must be "predominantly for the supply of the domestic
market". For more information on the procedures relating to com-
pulsory license please refer to the TWN Manual at:

If a pharmaceutical product is patented in India, it cannot sim-
ply manufacture and export. The Indian government will have to
issue a compulsory license to manufacture and the manufacturing
must be "predominantly" to supply the Indian domestic market.
Only the balance (the non-predominant portion) can be exported.

In recognition of this problem paragraph 6 of the Doha Declara-
tion directed that a solution be found. After months of debates,
a temporary agreement to address the problem was finally reached
on 30 August 2003 (the Decision). The Decision outlines various
procedures that importing and exporting countries have to fol-
low. Many have criticized this Decision as cumbersome and diffi-
cult to use. A Statement was also read by the Chair that pre-
sided over the meeting that came up with the Decision (Chair-
man's Statement). The Chairman's statement further requires more
cumbersome procedures to be followed. Both the August Decision
and the Chairman's statement came about following intense pres-
sure from the multinational pharmaceutical companies in the de-
veloped countries particularly the US.

The 30 August Decision can be found at -

The Chairman's Statement can be found at -

The Africa Group submitted early this year a proposal to make
the temporary agreement, permanent by amending the TRIPS Agree-
ment as well as proposed the removal of the many procedures
found in the August Decision. The Africa Group does not want to
make any reference to the Chairman's statement. Brazil and India
have found the Africa Group proposal to be a good basis for dis-
cussion on how to amend the TRIPS Agreement. Brazil and India
are not happy with the way the consultations on this matter have
taken place.

The US and European Community (EC) are not in agreement with the
Africa Group proposal. They do not want to change any aspect of
the August Decision and the Chairman's statement. Of particular
concern is to the developed countries is the legal status of the
Chairman's statement.

For now (pending a permanent resolution of this matter), coun-
tries that wish to import a product that is patented in the
manufacturing country (e.g. in India), there may be a need to
use the 30 August Decision. To learn about when the 30 August
Decision is triggered and the procedures that are required to be
complied to produce, export and import generic medicines, please
refer to the WHO publication to be found at:

Further Resources:
For More information on the history and current Paragraph 6 Ne-
gotiations please click - http://www.cptech.org/ip/wto/p6/

Text of the TRIPS Agreement -

Please do not hesitate to contact us should you wish to have
further information.

Impasse on talks on TRIPS and Health "permanent solution"

An impasse became evident on negotiations on the major remaining
issue relating to the TRIPS Agreement and Public Health when
some key WTO members appeared far apart on a solution, and dis-
agreed even on how the process of consultations is going on,
during a meeting of the TRIPS Council on 25 October.

Some developing countries, particularly Brazil and India, com-
plained that they had been left out of consultations taking
place between a few countries. They also reiterated their sup-
port for the proposal by the African Group as a good basis for
negotiations towards a solution.

African countries indicated that they were prepared to engage
with others, and quoted a declaration by the African Health Min-
isters for the need to find a permanent solution that removes
all constraints and procedural requirements to the export and
import of generic medicines.

The US was adamant that a solution must include the statement of
the Chair of the General Council before the adoption of a deci-
sion on 30 August 2003. However, India, Brazil and other devel-
oping countries did not want a solution in which the Chairman's
statement is upgraded to a higher legal status than what it now

The issue at hand is the TRIPS Council's search for a "permanent
solution" to ensuring access to medicines for countries that
have no or inadequate drug manufacturing capacity.