The rhetorical war over access to pharmaceuticals in poor countries admits to no middle ground. On one side are public health activists along with health officials in developing countries, who see any attempt to price drugs significantly above their manufacturing costs as an outrage. The World Health Organization concurs: "In many countries, patents hamper the public's access to life-saving medicines -- in other words, profits are being put before public health."
On the other are western drug companies and their governments, who argue that intellectual property rights must be respected and prices set high enough to cover the vast R&D costs of the next generation of life-saving compounds. As Miles White, a former chairman of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) put it, "We must extend the benefits of innovation to those who need them; but, first, we must have that innovation. If we take away the fuel, the fire will soon burn out."
Happily, though, the gulf is more apparent than real -- a point worth some special attention this week, as delegates from around the world convene at the XIX International AIDS Conference in Washington, DC. One reason is that (unbeknownst to the media) most of the drugs needed in poor countries are not under patent. The other is that, beneath the belligerent façade, cooler heads are prevailing: While governments have failed to chart a way forward in high-profile negotiations, drug producers are recognizing that solutions increasing medical access without sacrificing maintaining intellectual property protection really are possible. In fact, a path-breaking deal between California-based Gilead Sciences and Indian generic drug maker Matrix offers a model for how it can be done.
Debates over intellectual property protection for drugs occur in many bodies worldwide, most of which have a dog in the fight. In the legislative battle over U.S. health care reform, for example, pharmaceutical companies were able to brush aside efforts to open the border to cheaper imported medications. By contrast, the World Health Assembly, the one-country, one-vote governing body of the World Health Organization, regularly proclaims the need to increase drug access. And though these statements rarely lead to substantive policy changes, western pharma still sees them as threatening.
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But since its inception in 1994, the World Trade Organization has been the primary battleground. The WTO's founding charter details members' responsibility to protect IPR in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS, for short). Many WTO signatories, notably India, initially offered no pharmaceutical product patent protection, and so negotiated a transition period until 2005 to establish product patents. The transition period for the 32 "least developed" countries extends through January 1, 2016.
Some health activists and developing country officials protested that TRIPS undermined nations' ability to intervene in domestic health emergencies. This led to the 2001 Doha Declaration on TRIPS and Public Health, which "affirmed the sovereign right of governments to take measures to protect public health." Two years later the WTO went a step further, allowing developing countries lacking manufacturing capability to bestow their emergency patent exemption on another country. Pharmaceutical companies in the designated country could then sell relevant drugs to the country in need.
Disagreements over other IPR measures -- notably trademark enforcement -- are ongoing and were stoked by the signing of the Anti-Counterfeiting Trade Agreement (ACTA) in October 2011. Although ACTA has not yet been ratified, India worries that its large generic manufacturing industry will be targeted. This spring, at the WTO's TRIPS Council India continued attempts to limit WTO influence over issues of drug quality. The Indian government concluded that IPR issues were "distinct from issues of quality and safety," and not part of the WTO mandate.