[1]courtesy of rodrigo senna flickr creative commons
After a protracted standoff, the world’s least-developed countries have reportedly won a 17-year extension of a waiver from world trade rules.
The extension was sought so that non-profits, health programs and generic drug makers working in those 48 countries could make, import or export medicines for life-threatening diseases without fear of being sued for patent infringement. As we noted previously [2], an existing waiver was put in place 15 years ago as part of a World Trade Organization agreement, which expires on Jan. 1, 2016.
The agreement was reached after weeks of haggling in which the LDCs sought an indefinite waiver, while the US Trade Representative Michael Froman objected to such a move and attempted to impose a 10-year cap. Under WTO rules, the countries have the right to seek an unconditional extension and believe that a waiver is warranted, at least until their economies improve.
Nazrul Islam, the deputy permanent representative of Bangladesh, and who chairs the LDC group, told Inside Trade that a deal was reached last week and is expected to be formally approved during a WTO council meeting on Nov. 13. We asked the US Trade Rep, whose office coordinates US trade policy, for comment and will update you accordingly.
Several governments and organizations backed an unconditional waiver, including the European Commission [3], the Vatican [4], and several United Nations agencies, including the World Health Organization [5]. Other supporters included the European Federation of Pharmaceutical Industries and Associations, an industry trade group, and Bernie Sanders, the US Senator from Vermont and presidential hopeful.
The effort also received backing from dozens of patient advocacy groups, which argued the US was placing the needs of the global pharmaceutical industry above patients by pressing for more restrictive intellectual property rules.
We asked the Pharmaceutical Research and Manufacturers of America, which is the industry trade group in the US, for comment and will pass along any reply. Last month, the group would only say that any waiver extension should be “time-based,” another way of saying the waiver should be limited.
While some feared a 10-year waiver, patient advocates were, nonetheless, disappointed with any time limit. “The deal falls short of what was asked and needed,” said Jamie Love, who heads Knowledge Ecology International, an advocacy group that focuses on access to medicines issues, in a statement.
“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,” he said. “Any temporary waiver, even one for 17 years, makes it less likely that governments will change the laws on the books.”
Placing a time limit on the extension is like “kicking the can down the road, forcing this difficult debate to resurface,” said Rohit Malpani, director of policy and analysis for the Doctors Without Borders access to medicines campaign. “Unless LDCs are granted an exemption until they graduate from their status as LDCs, they’ll have to keep revisiting this debate.”