[Ip-health] WTO Decision on Least Developed Country (LDC) Drug Patent Waiver

Zack Struver zack.struver at keionline.org
Tue Nov 3 07:22:08 PST 2015

WTO Decision on Least Developed Country (LDC) Drug Patent Waiver

Source URL: http://keionline.org/node/2354

Submitted by Zack Struver on 2. November 2015 - 18:00

For Immediate Release
3 November 2015
Contact: Zack Struver, +1 (202) 332-2670 or zack.struver at keionline.org

Geneva — The World Trade Organization is poised to announce this Friday its
approval of a limited 17-year extension of a 2001 waiver of obligations in
the TRIPS Agreement, set to expire at the end of this year, the terms of
which exempt Least Developed Countries (LDCs) from requirements to grant
patents or related intellectual property rights on pharmaceutical products.

The decision to grant the 17-year waiver represents a compromise between
the United States, which had asked for a ten-year waiver, and Least
Developed Countries, which wanted an indefinite extension of the waiver
that would have lasted for as long as a country remained least developed
per UN classification. An indefinite waiver would have been a clear victory
for LDCs, as it would have recognized their needs above the United States’
continuing promotion of more restrictive intellectual property rules.

Those who supported an indefinite extension of the waiver far outnumbered
those who opposed it, and included the governments of all developing
countries; U.N. agencies, such as the World Health Organization, the Joint
United Nations Programme on HIV/AIDS (UNAIDS), and the United Nations
Development Programme (UNDP); the European Union; the Vatican; various
members of the United States Congress, including presidential candidate
Sen. Bernie Sanders (I-Vt.); and leading public health non-governmental
organizations, including Doctors Without Borders (MSF), Oxfam, Health GAP,
Public Citizen, Third World Network (TWN), the Union for Affordable Cancer
Treatment (UACT), Knowledge Ecology International (KEI), and dozens of NGOs
in least developed countries.

The United States opposed an indefinite waiver, instead asking for a
ten-year extension, with reports from informed sources [2] indicating that
the Obama administration was in part motivated by pharmaceutical industry
complaints that the U.S. Trade Representative (USTR) had had failed to
“deliver” on stringent patent regulations in the Trans-Pacific Partnership.
In a June presentation at the WTO [3], LDCs called a time limited waiver
“unconscionable,” and said that anything less than an indefinite waiver
“jeopardizes the health situation of the people and communities within

As over 100 NGOs, including groups in LDCs [4] and the United States [5],
have pointed out, governments will not amend their patent laws to allow for
the manufacture or distribution of low-cost generic drugs without the
certainty of an indefinite extension.

Access to generic medicines is essential for the long-term stability of
health systems in LDCs. Almost 1 billion people live in LDCs, most of them
in extreme poverty. In 2014, per capita healthcare spending was less than
$50 in LDCs, and the per capita income was only $915. Neither patients nor
governments can afford expensive brand name drugs in LDCs, which are home
to over 10 million of the world’s HIV/AIDS patients.

James Love, the Director of Knowledge Ecology International, said:

“The decision to extend the WTO waiver of drug patent rules for 17 years is
a better outcome than the 10 year waiver proposed by USTR head Ambassador
Michael Froman, but it is also a disappointment, and falls short of what
was asked and needed. Least developed countries need to amend their patent
laws, so that the ability to make, import and export generic drugs will not
be restricted by drug patents. Any temporary waiver, even one for 17 years,
makes it less likely that governments will change the laws on the books.
The previous waiver did not lead to the types of legal reforms that make
sense for very poor countries, for that reason.

The typical previous response to a temporary WTO waiver, embraced by many,
including PEPFAR funded NGOs, was to ask LDCs for non-enforcement of
patents. In the short term, that will probably continue, but at the same
time, USTR and the EU are pushing for changes in the rules on the
enforcement of drug patents, and expanding liability for third parties who
can be held liable for infringement of patents, even across borders. USTR
aligned itself with drug companies, to prevent a more sustainable and
durable change in WTO rules and national patent laws. The Obama
Administration trade policy continues to favor drug companies over poor
people, and to prop a system that needs to be fixed and changed, and not

By being the most aggressive in opposing a permanent waiver for LDCs, and
by resisting longer terms for a time limited waiver, President Obama,
Ambassador Michael Froman (U.S. Trade Representative), and Ambassador
Michael Punke (U.S. Permanent Representative to the WTO) have shown they
are unsympathetic to millions of poor people living in Least Developed
Countries, who are still suffering from a lack of basic resources,
including affordable medicines.”

For more information on the drug patent waiver and U.S. opposition, visit
KEI’s website: http://keionline.org/node/2342. Please direct questions to
Zack Struver at +1 (202) 332-2670 or zack.struver at keionline.org.

[2] http://keionline.org/node/2337
[3] http://keionline.org/node/2245
[5] http://keionline.org/node/2347

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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