Xu 1 From: Zhihong Xu To: Ambassador Eric Goosby and Ambassador Ron Kirk Subject: United States policy regarding

intellectual property in terms of AIDS response Date: October 23, 2012 TF: Erik Heinonen Purpose: The United States must address the ramifications of the Trade-Related Aspects of Intellectual Property Rights (TRIPS)-Plus trade agreements on public health in HIV-prevalent areas such as sub-Saharan Africa and Southeastern Asia. This policy memo seeks to gather consensus on an appropriate course of action for the United States to facilitate AIDS treatment and HIV prevention in the most affordable and efficient manner. Background: The United States has recently carried out a series of secret negotiations that has resulted in more stringent guidelines regarding the protection of intellectual property. While intellectual property is of the utmost importance to the well-being of the economy, public health is being jeopardized by the series of new agreements known collectively as TRIPS-Plus. The agreements call for data exclusivity, the extension of a patents life through evergreening methods, and the restriction of compulsory licenses for generic manufacturers. 1 With TRIPSPlus constricting the lifeblood of generic pharmaceutical companies (ARVs), the millions relying on ARVs risk losing access to these life-saving drugs purely due to cost. The data exclusivity clause further serves to impede the flow of drugs into HIV-burdened areas; the records of clinical trials of innovative drugs are locked away for years. Should other companies wish to put the drug into the market, they are forced into the unethical position of conducting the trials again. The United States, by jeopardizing the health of millions and the stability of regions, has been criticized by the international community for its firm stance on TRIPS-Plus; we must reevaluate TRIPS-Plus in order to better balance the needs of humankind with the need for intellectual property rights. Discussion of Course of Action: The United States has a vested interest in both sub-Saharan Africa and Southeastern Asia. Africa is home to vast resources such as oil reserves that help fuel the economy in the United States. 2 The Association of Southeast Asian Nations (ASEAN), comprised of countries such as the Philippines and Malaysia, represents a major trading partner for the United States. ASEAN, collectively accounting for $272 billion in trade, is the fifth largest trading partner of the United States.3 Given the importance of both global regions, the United States must proceed in a manner that serves to ensure financial and political stability within the regions. Without proper healthcare for the locals, the market and political structure cannot sustain themselves; the United States should turn towards humanitarian assistance to reinforce its interests within the regions.

"TRIPS, TRIPS Plus and Doha." MSF Access Campaign. N.p., n.d. Web. 20 Oct. 2012. <http://www.msfaccess.org/content/trips-trips-plus-anddoha>. "United States Department of Defense." Defense.gov. N.p., n.d. Web. 20 Oct. 2012. <http://www.defense.gov/speeches/speech.aspx?speechid=943>. "US Interests in Southeast Asia Challenged by China." Epoch Times. N.p., n.d. Web. 22 Oct. 2012. <http://www.theepochtimes.com/n2/unitedstates/us-interests-in-southeast-asia-china-46552.html>.

Xu 2 TRIPS-Plus contradicts the public health policy that President Barack Obama has laid out in his agenda to increase ARV access to six million up from the current goal of four million people worldwide by 2013.4 In order for President Obama to meet the desired goals, reforms must be made to TRIPS-Plus. Several options can be considered for increasing ARV access to people at affordable prices. The United States could alter its patent policy by reducing the lifespan of medical patents from twenty years to ten years and preventing the evergreening of current patents. Such actions would allow generic manufacturers to provide cheaper drugs to patients in a timelier manner in two ways: by providing access to the intellectual property sooner and by ensuring that patents that fail to alter a drugs purpose cannot be renewed. While this plan would ensure lower prices for patients, medical and pharmaceutical companies will protest due to smaller profit margins from their innovations; consequentially, investment in vital research and development will decrease. Furthermore, a worrisome precedent could be set, causing companies and individuals from all sectors to lose faith in the patent protection system that the United States has created. Due to these consequences, it is not in the best interest of the United States to pursue this policy. Another alternative to circumvent the TRIPS-Plus policies is to create a clause much like the Doha Declaration that would prevent data exclusivity and allow for ease in issuing compulsory licenses for life-saving drugs such as ARVs. The clinical trials of revolutionary medicines with the potential to save millions of lives cannot be locked away; the prices of lifesaving medicines ought to be lowered so that patients can receive life-saving treatment before it is too late. The United States, being the largest exporter of intellectual property, would remain on firm ground in protecting the status of patents while serving the interests of people around the world by allowing exemptions to TRIPS-PLUS for issues that compromise the health of a nation. Generic industry would have the means to create and distribute cheap ARVs to the targeted six million people. Opponents argue that medical industries would suffer because they could no longer profit from their patents. However, the health and well being of a nation exceed the desires of a company. It is actually in the economic interest for the United States to provide cheaper drugs; HIV alone in South Africa has led to a twelve percent decline in labor productivity and a three percent decrease in real gross domestic product.5 With similar figures found within Southeastern Asia, the benefits of more productivity from citizens ultimately leading to a higher level of trade outweigh the economic consequences of having nations fund ARV programs and allowing nations to create exceptions in intellectual property protection in cases of public health. Recommendation: In the social and economic interests of the United States and HIV-burdened areas, the United States should adopt a policy that allows for disclosure of clinical trials and intellectual property in instances where life-saving treatment needs to be distributed to the population. I urge that Ambassador Goosby and Ambassador Kirk adopt this strategy of promoting public health for humankind.

Bohan, Caren, and Alina Selyukh. "Obama Raises U.S. Goal on Fighting AIDS." Reuters. Thomson Reuters, 01 Dec. 2011. Web. 20 Oct. 2012. <http://www.reuters.com/article/2011/12/01/us-obama-aids-idUSTRE7B01H320111201>. Collins-Chase, Charles T. "THE CASE AGAINST TRIPS-PLUS PROTECTION IN DEVELOPING COUNTRIES FACING AIDS EPIDEMICS." Www.law.upenn.edu. University of Pennsylvania Law School, n.d. Web. 22 Oct. 2012. <https://www.law.upenn.edu/journals/jil/articles/volume29/issue3/CollinsChase29U.Pa.J.Int'lL.763(2008).pdf>.

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Works Cited Bohan, Caren, and Alina Selyukh. "Obama Raises U.S. Goal on Fighting AIDS." Reuters. Thomson Reuters, 01 Dec. 2011. Web. 20 Oct. 2012. <http://www.reuters.com/article/2011/12/01/us-obama-aidsidUSTRE7B01H320111201>. Collins-Chase, Charles T. "THE CASE AGAINST TRIPS-PLUS PROTECTION IN DEVELOPING COUNTRIES FACING AIDS EPIDEMICS." Www.law.upenn.edu. University of Pennsylvania Law School, n.d. Web. 22 Oct. 2012. <https://www.law.upenn.edu/journals/jil/articles/volume29/issue3/CollinsChase29U.Pa.J. Int'lL.763(2008).pdf>. "TRIPS, TRIPS Plus and Doha." MSF Access Campaign. N.p., n.d. Web. 20 Oct. 2012. <http://www.msfaccess.org/content/trips-trips-plus-and-doha>. "United States Department of Defense." Defense.gov. N.p., n.d. Web. 20 Oct. 2012. <http://www.defense.gov/speeches/speech.aspx?speechid=943>. "US Interests in Southeast Asia Challenged by China." Epoch Times. N.p., n.d. Web. 22 Oct. 2012. <http://www.theepochtimes.com/n2/united-states/us-interests-in-southeast-asia-

china-46552.html>.