U.S. Praises WTO Deal Giving Poor Countries Access to Medicine

USTR Portman views agreement as helping countries devastated by HIV/AIDS

By Bruce Odessey
Washington File Staff Writer

Washington -- The United States has welcomed World Trade Organization (WTO) approval of an agreement resolving a long-standing impasse over developing countries’ access to inexpensive copies of patented drugs for treating HIV/AIDS, malaria, tuberculosis and other illnesses.

The WTO General Council made permanent December 6 a waiver from an existing intellectual property protection agreement for poor countries with little or no pharmaceutical manufacturing capacity to secure drugs through what is called compulsory licensing.

"This is a landmark achievement that we hope will help developing countries devastated by HIV/AIDS and other public health crises," U.S. Trade Representative Rob Portman said in a written statement.

WTO members reportedly were eager to close the deal on pharmaceuticals for developing countries ahead of the December 13-18 ministerial meeting in Hong Kong. 

"The Africa Group and other developing countries made clear that the amendment was something they saw as essential to accomplish before Hong Kong," Portman said, "and we were pleased to work with them to make it happen."

At issue is a waiver to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).   The General Council approved that waiver temporarily in August 2003; now it has approved it permanently as a TRIPs amendment.

Part of the delay can be attributed to wrangling over how to prevent diversion of the generic drugs from poor countries to the profitable commercial market.

Under compulsory licensing a government can allow a manufacturer to produce a patented product or use a patented process without the consent of the patent owner (although the patent owner has the right to "adequate remuneration," according to TRIPs).

The TRIPs agreement already allowed compulsory licensing, but only for domestic consumption.  The waiver allows generic copies made under compulsory licences to be exported to countries that lack production capacity to produce such copies themselves, provided that certain conditions and procedures are followed.

WTO members have until December 2007 to accept the TRIPs amendment, which would go into effect, for those members that adopt it, once two-thirds of WTO members have adopted it. The waiver remains in place until the amendment is in force.

According to reports of the General Council meeting, the final agreement included a statement made for the record by the council chairman warning that "the amendment should be used in good faith to protect public health and ... not be an instrument to pursue industrial or commercial policy objectives."

Specifically, the chairman's statement warned against diversion of any generic copies of patented drugs from the intended developing countries into the profitable commercial market.  Western drug companies that hold the patents on most of the drugs concerned have raised the threat of such diversions.

The USTR press release and a related fact sheet are available on the USTR Web site.

Created: 06 Dec 2005 Updated:30 Jun 2008