[Ip-health] UN Agencies Call for "Full Use" of WTO Rules on Access to Medicines
sflynn at wcl.american.edu
Thu Mar 17 07:15:10 PDT 2011
World Intellectual Property Report: News Archive
Patents: UN Agencies Call on Developing Countries to Make "Full Use" of
WTO Rules on Access to Medicines
UN Agencies Call on Developing Countries to Make "Full Use" of WTO Rules
on Access to Medicines
GENEVA - Developing countries need to make greater use of flexibilities
under World Trade Organization intellectual property rules to override
patent rights on drugs and address a serious shortage of HIV/AIDS
treatments, three United Nations agencies said on March 15.
In a joint policy brief, UNAIDS, the World Health Organization (WHO) and
the UN Development Program (UNDP) said the flexibilities contained in
the WTO's Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPs) and reaffirmed by the 2001 Doha Declaration on TRIPs and
Public Health "provide important opportunities for WTO Members to reduce
prices and expand access to HIV medicines."
"Countries revising their laws should use to the full the flexibilities
contained in the TRIPS Agreement," the UN agencies said.
Dr Paul de Lay, UNAIDS Deputy Executive Director, said some 15 million
people around the world are in need of antiretroviral therapies, but
only around a third - or 5 million people - are currently receiving
"In 2009 we saw for the first time in 10 years a flat lining of overall
global HIV resources," de Lay declared. "With reductions in funding,
it's clear we have to do things differently, with less, in order to
scale up the treatment."
"The TRIPs flexibilities is one tool that can be particularly effective
in bringing down the cost of medicines," he added. "However, use of the
TRIPs flexibilities to date has been limited.
The UN agencies said that while the cost of first-line retrovirals for
low-income countries has gone down dramatically, falling 99% over the
past decade to US$116 for the cheapest treatment, "prices are still too
high for many low- and middle-income countries, especially for
In August 2003, WTO members followed up the Doha Declaration with the
so-called "Paragraph 6" decision allowing developing countries to issue
compulsory licenses for the import of generic copies of patented
medicines and for developed countries to allow production of the
medicine for export to poor nations.
The agreement addresses an anomaly in the TRIPs that authorized
governments to issue compulsory licenses only if the license is used
"predominantly" for the supply of the domestic market, effectively
preventing poor countries with no pharmaceutical industry from utilizing
However, the mechanism under the 2003 agreement has been used only once,
by Rwanda, to import generic copies of a patented HIV/AIDS treatment
from Canada. That has prompted developing countries to question whether
the requirements for using the mechanism are too strict.
In addition to the provisions on compulsory licensing, the TRIPs
agreement also allows for various forms of parallel imports (under
so-called "international exhaustion" rules) and the use of a patented
drug without authorization in order to obtain marketing approval for a
generic drug before the patent expires ("Bolar" provisions).
UN officials admit the Paragraph 6 decision has been less than
successful in practice and has probably contributed to the low use of
the TRIPs flexibilities among developing countries.
"The flexibilities may or may not be the easiest to use, but the reality
is that they are one tool in the armory right now, and we have to use
what we can, because it's a very urgent situation," declared UNDP's Dr
Mandeep Dhaliwal. "We recognize that they're not the simplest mechanisms
to use, and that's why there probably hasn't been as much uptake of the
flexibilities and incorporation into national legislation as we would
have hoped for."
The UN agencies cited a World Intellectual Property Organization which
found that just over half of 95 countries surveyed had incorporated
Bolar provisions in their national legislation while just over a quarter
of the 112 countries surveyed had international exhaustion rules for
The real success of the TRIPs flexibilities however may be in their use
by some governments as a means of pressuring drug companies to lower
prices of patented medicines. The policy brief cited the example of
Brazil which, using the threat of compulsory licensing, negotiated
significant price reductions for a number of antiretrovirals.
"It is estimated that the Brazilian Government's policies, including the
use of TRIPS flexibilities, saved approximately US$1.2 billion on
antiretroviral drug purchasing costs between 2001 and 2005," the UN
More controversially, since late 2006 Thailand has issued compulsory
licenses for a number of patented drugs, including non-HIV treatments
such as heart disease and cancer treatments. In 2007 the Office of the
US Trade Representative put Thailand on its Special 301 priority watch
list of countries not protecting intellectual property rights.
By Daniel Pruzin
Sean M Fiil Flynn
Program on Information Justice and Intellectual Property
American University Washington College of Law
Washington D.C. 20016
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