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Show THE UNIVERSITY OF UTAH CHARLES H. MONSON PRIZE WINNER However, it is important to note that only a very small portion of drug companies' profits on HIV/AIDS drugs come from resource-limited countries. In fact, over 90 percent of profits on these drugs c o m e exclusively from the United States and Europe (Star-Ledger Editorial Board, 2011). Therefore, if less than 10 percent of profits c o m e from developing countries, it begs the question of w h y many drug companies are staunch in their refusal to lower drug prices significantly in these countries. Role and Efficacy of Compulsory Licensing and Parallel Importing In spite of TRIPS' role in allowing drug corporations to maintain extended exclusive patents on their drugs, thus increasing prices to oft-prohibitive levels for people in resource-limited countries, two provisions within TRIPS attempt to increase accessibility to essential medicines for countries in dire need. Essential medicines are determined by the W H O to be "those that satisfy the primary health care needs of the population" (de Lima, 2009). Compulsory licensing and parallel importing are provisions within the agreement that provide two means by which less-developed countries can access HIV/AIDS medications and other essential medicines. The first, compulsory licensing, allows the proposed licensee to receive a license to produce and distribute a patented product without the patent holder's consent. If it is not a case of national emergency, efforts must be made to have the license granted voluntarily by the drug company; however, if the drug company refuses to grant the license, "a non-exclusive license can be granted by the government" (Subhan, 2006). Furthermore, in cases of "national emergency or other circumstances of extreme urgency," efforts to obtain a license issued voluntarily by the patent holder need not be made (General Council of the World Trade Organization, 2003). However, one caveat of compulsory licensing is that TRIPS specifies that the provision must be used "predominantly for the supply of the domestic market of the Member authorizing such use" (World Trade Organization, 2006). While this specification is necessary in order to ensure that illegal transnational transport and trade of pharmaceuticals does not ensue, it makes this provision more difficult for less-developed countries to take advantage of. Although the provision is designed for their benefit, to increase accessibility to expensive drugs, the aforementioned specification means that these countries must manufacture the drugs themselves, which is exceedingly difficult because of the lack of infrastructure and technology necessary for such a sophisticated industry. Furthermore, countries with small domestic markets may not be able to sustain production economically (Haakonsson & Richey, 2007). If attempting local production is most likely unprofitable, few countries will choose to engage. Therefore, only a small number of countries have utilized compulsory licensing, indicating that, in its current state, this provision is not notably efficacious in increasing accessibility to HIV/AIDS medications to those in resource-limited countries. The other main TRIPS provision, parallel importing, allows less-developed countries to import patented medications from other countries, where they are sold for a lower price. This effectively allows said countries to purchase these medications for the lowest global price (Subhan, 2006). This importation may be done without the authorization of the patent holder in the country where the drug is being sold at a lower price. This is a tremendous opportunity for less-developed countries to obtain lifesaving pharmaceuticals to treat their infected populations. However, very few countries have taken advantage of TRIPS'allowance of parallel importing. O n e reason for this is that the process of parallel importation is still fraught with bureaucratic procedures, confusing guidelines, and political pressure (Wise, 2006). Furthermore, in order for developing countries to make full use of TRIPS' provisions, they must review and implement patent laws, providing a legal structure through which TRIPS can operate (Wise, 2006). Few countries have dedicated the resources to do this, hindering their ability to make use of parallel importation. As aforementioned, political pressure is a factor that has made less-developed countries timid to engage in compulsory licensing or parallel importing. These countries do not want to risk 49 |