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

Knowledge Ecology International; November 3, 2015. 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 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, 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 LDCs.”

As over 100 NGOs, including groups in LDCs and the United States, 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 defended.

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@keionline.org

Read more:

MSF’s response  to the LDC pharma waiver deal

High-Level Negotiations On LDC Pharma IP Waiver Extension At WTO

U.S. opposition to drug patent waiver will harm world’s poorest patients

Unconditional 17-year exemption from pharmaceuticals patents agreed

This entry was posted in August 30 decision, LDC transition period, LDCs, TRIPS. Bookmark the permalink.

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