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In the latest flare up over access to medicines, the world’s least-developed countries are seeking an indefinite waiver from world trade rules so they can remain exempt from granting and enforcing pharmaceutical patents. But the U.S. Trade Representative is objecting to the move.

At issue is the ability of non-profits, health programs and generic drug makers working in those 48 countries to make, import or export medicines for life-threatening diseases without fear of being sued for patent infringement. An existing waiver, which was put in place 15 years ago as part of a World Trade Organization agreement, expires on Jan. 1, 2016.

These poor countries have the right to seek an unconditional extension under WTO rules and believe a waiver is warranted, at least until their economies improve, according to patient groups. “These countries have some of the biggest health needs and fragile health systems,” says Judit Rius, U.S. manager and legal policy adviser for Doctors Without Borders. “They need access to generics.”

But U.S. Trade Representative Michael Froman is objecting to an unconditional extension, according to a letter that U.S. Sen. Bernie Sanders (I-Vt.) wrote yesterday in which he asked Froman to reconsider his position. The extension, Sanders argued, could provide the countries “a better chance at building and maintaining public health infrastructure designed to contain global threats.”

Instead, Froman is seeking to place limits on any extension, although the types of limits being sought or trade-offs proposed are not clear and worry some patient advocates. Ruis says she and several others met with members of the U.S. Trade Rep’s office this month, but staffers did not disclose specific demands other than to acknowledge that talks are being held with least-developed countries.

We asked the U.S. Trade Rep for a response and will update you accordingly.

The waiver issue is gaining increasing attention because a WTO council meets in Geneva in mid-October to review the request from the least developed nations. To date, the countries have gained considerable support for the position, winning the backing of the World Health Organization, the European Commission and the Vatican.

“We have before us a critical opportunity to help LDCs to reach health and sustainable development goals and the failure to do so could put millions of lives at risk,” Archbishop Silvano Tomasi, permanent observer of the Holy See to the United Nations wrote to the WTO in June. He called for “a sense of common responsibility” in helping the countries.

Some patient advocates, meanwhile, are lashing out at the U.S. Trade Rep for what they see as an effort to thwart the waiver. In their view, the U.S. Trade Rep is doing the bidding of the pharmaceutical industry, which is battling to maintain intellectual property rights, according to Brook Baker, a law professor at Northeastern University and a senior policy analyst for Health GAP, an advocacy group.

Patient advocates fear that a failure to extend the waiver indefinitely or place restrictions will result in a standstill. Specifically, they worry that the least developed countries will choose not to upgrade their patent laws and, meanwhile, generic drug makers will not make investments needed to produce low-cost medicines for those populations.

In response to the Sanders letter, Peter Pitts , a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry, wrote us to say that “the world’s poor cannot access innovations that do not exist. And without fair protection on intellectual property there is no incentive to innovate.”

As for the pharmaceutical industry itself, a spokesman for the Pharmaceutical Research & Manufacturers of America, the trade group, declined to comment about the jousting, but did say that a waiver should be “time based.” In other words,  the trade group favors some type of limit on an extension.

Separately, an astute reader reminds us that the European Federation of Pharmaceutical Industries and Associations issued a statement supporting the waiver request.