Congressman Henry Waxman (D-CA), through the House Committee on Oversight and Reform, sent a letter to Susan C. Schwab, the U.S. Trade Representative yesterday that urged her to focus on access to medicines for those treatments that were life-saving weighing intellectual property (IP) interests against public health needs. At issue is whether compulsory licensing is permitted by the WTO TRIPS agreement. The letter asked her to focus on matters that relate to public health vis a vis access by developing countries to life-saving medicines.
Last year, Thailand issued compulsory licensing on several medications. One was for HIV, one was for blood thinners. It has since been a matter of considerable controversy.
"Specifically, in determining whether a public health measure raises concerns regarding the "adequate and effective" protection of intellectual property rights, you should consider not only the extent to which greater property rights and protections could enhance innovation, but also the United States’ commitment to respecting measures that improve access to life-saving medicines in developing countries."
The question that rises from the debate is this – when does a medication infer life-saving treatment and when is it not? Is a diabetes treatment life-saving? Where is the line drawn?
"In fact, TRIPS does not limit compulsory licenses to "emergencies," but rather, as discussed above, permits countries to determine when they are necessary."
Does the agreement put the purview of life-saving in the host country? Is the issue as simple as is outlined in the letter? The issue of life-saving is somewhat subjective. This letter raises the question about where the dominant political party will take intellectual property in the coming years. And it begs for a definition of what is meant by "life-saving", but who is the ultimate authority for such a determination?
This raises the debate to a new level. What is the threshold of life-threatening? And what is the threshold by which access to medicines in developing countries becomes an issue for the future viability of intellectual property to preserve innovation, a topic not mentioned in the letter? I don’t pretend to know the answer, but the question is surely to be debated in the coming election cycle, and what is to follow.