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 them.
"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 second-line
regimens."
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 the provisions.
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 parallel imports.
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
agencies said.
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.
Keywords: UN Agencies / WTO / Developing countries /
Medicines
