Pe7 - andré de mello e souza

1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over
Pharmaceutical Patent Rights1
André de Mello e Souza 1) Introduction This article discusses the efforts of transnational advocacy networks to change institutions of global governance that relate to intellectual property so as to increase access to essential medicines in resource-poor areas of the world. The most important of these institutions is the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS requires that all World Trade Organization (WTO) members recognize patent rights for all fields of technology, including pharmaceuticals. However, because patent rights create monopolies, they increase the costs of patented medicines, rendering them unaffordable to the world's poor. In alliance with developing countries, networks have reframed IP negotiations in terms of human and health rights and used information strategically to pressure the United States government - which has generally championed higher global standards of IP protection and acted on behest of the pharmaceutical brand name industry – to bring about institutional change at the international level. The transnational campaign for access to essential medicines has aimed primarily at the dissemination of generic medicines in the world drug market. Activists consider such dissemination of generics as crucial for their purposes because pharmaceutical multinationals will not lower the prices of their brand-name drugs sufficiently and for all the patients in need unless they are faced with competition from other producers, or threats thereof. Tiered pricing schemes voluntarily set up by the brand-name pharmaceutical industry in response to network pressures may work temporarily and help to attenuate the costs of life-saving medicines, but any long-term, sustainable reduction of such costs must focus on structural factors that grant this industry monopoly powers and that constitute integral components of the patent system under TRIPS. In light of the goal to promote generic competition, activists have targeted several different actors at different levels of policymaking, including the US government and non-generic pharmaceutical companies. They have operated domestically as well as in multilateral venues. They have used information strategically to shame and persuade 1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over
Pharmaceutical Patent Rights1
André de Mello e Souza these actors, and thereby change patent and health policies and institutions. This article focuses exclusively on the operation of advocacy networks at multilateral forums, and argues that they have significantly influenced the preferences and negotiating capacities of developing countries, thereby reshaping international IP regimes. Multilateral negotiations on pharmaceutical patent rights offer a hard case for testing the impact of non-governmental organizations (NGOs) on the institutions of global governance. First, not only was there a considerable asymmetry of material power between these networks and the governments and multinational corporations they confronted, but there was also the impossibility of using what Margaret E. Keck and Kathryn Sikkink have called "leverage politics" or the "boomerang pattern of influence".1 Indeed, the main target of networks in this case was the US, the world's hegemonic state, and they had therefore no greater power to resort in order to bring material leverage upon this target. Because of this, networks have had to rely solely on the strategic use of information, on the force of its moral claims, and on persuasion. The case of IP therefore allows the isolation of the effects of material leverage from moral leverage in transnational advocacy. It thereby also allows investigation of the mechanisms through which such moral leverage impacts targets in the absence of material leverage. In addition, IP has been an issue-area characterized by high technical complexity, and has therefore not been easily accessible to civil society groups or the general public. The challenge for transnational advocacy in this respect has been twofold. First, it had to create an epistemic community to master the legal and economic foundations of IP and to counter the claims of corporate and US governmental experts. Second, it has had to simplify, filter and translate the technical complexity of IP so as to make its demands intelligible and morally relevant to the general public. As Keck and Sikkink have pointed out, "an important part of the political struggle over information is precisely whether an issue is defined primarily as technical — and thus subject to consideration by ‘qualified' 1 Margaret E. Keck and Kathryn Sikkink, Activists beyond Borders: Advocacy Networks in International Politics (Ithaca, N.Y.: Cornell University Press, 1998): 12-13; 23-24. 1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over
Pharmaceutical Patent Rights1
André de Mello e Souza experts — or as something that concerns a broader global constituency."2 The fact that transnational advocacy networks have scored victories in the struggle over IP rights — at least on what concerns pharmaceutical patents — despite the disparities in power and expertise and the impossibility of using material leverage underscores the significance of these victories. The next section explains the main contentious rules of TRIPS in what regards access to essential medicines. In particular, it points to the options available under TRIPS to increase such access, why the international trade of generics is so important for this purpose, and the preferred outcomes of transnational campaigners. The third section argues that NGOs have empowered developing countries in multilateral negotiations and used information strategically to achieve their goals. As result, significant institutional shifts have occurred in several different forums. Most importantly, an agreement to amend TRIPS has been reached. The article concludes with a summary of the strategies used by transnational advocacy networks and of the theoretical significance of these networks for international politics. Particularly, the changes in the TRIPS agreement underscore how agency matters. Even though membership in international regimes is formerly limited to states, the politics of the IP regime cannot be adequately understood without taking into account the purposeful actions of non-state actors. Transnational advocacy networks worked within different and challenging IP institutional structures, but also reacted to and reshaped these structures in critical ways. 2 Keck and Sikkink, 19. 1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over
Pharmaceutical Patent Rights1
André de Mello e Souza 2) The Limits Imposed by TRIPS on the Use of Generics Restrictions imposed by the TRIPS agreement may severely limit developing countries' ability to produce generic drugs so as to increase competition and reduce prices in the pharmaceutical market. The exemption period granted by the agreement for least developed countries (LDCs) to adjust their legislations in accordance with TRIPS expires in 2016.3 After this deadline, the absence of patent laws or the maintenance of lax patent laws not in accordance with TRIPS in any WTO member country will constitute a violation of the agreement. The lack of patent legislation compliant with TRIPS is therefore unsustainable in most developing countries in the long-term. This means that, in order to locally manufacture copies of patented brand-name drugs these countries will need to either obtain voluntary licenses from (mostly foreign) patent-holders or to issue compulsory licenses.4 The first option is in practice unviable, given that pharmaceutical companies do not easily concede voluntary licenses and share their technological know-how and profits with local producers who are potential competitors unless these companies receive credible threats of having the monopoly rights of their patents overridden. As Abbott indicated, "for a variety of reasons, the technology needs of developing countries often may not be met by acquisition of technology licenses on voluntary terms. Compulsory licensing provides a means for developing countries to obtain technology necessary for development and social 3 TRIPS came into force on January 1, 1995. The agreement gave developed countries one year to comply and set the deadline for the compliance of developing countries and transition economies at January 1, 2000. However, those developing countries required to extend product patent protection to new areas such as pharmaceuticals were granted additional five years before such protection had to be introduced. LDCs must have enacted TRIPS by 2006, but the Doha Ministerial Declaration extended the deadline in what concerns pharmaceutical products for 10 years, to 2016. 4 According to P. Gorecki, "a compulsory license is an involuntary contract between a willing buyer and an unwilling seller imposed and enforced by the state." Cited in Anthony D'Amato and Doris Estelle Long, International Intellectual Property Law (London: Kluwer Law International, 1997), 357. Compulsory licensing allows the use of patented objects without the permission of the patentee, which receives royalties set by the state. In effect, the patentee is forced to license the object of the patent to others. 1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over
Pharmaceutical Patent Rights1
André de Mello e Souza welfare."5 Indeed, in the long-run compulsory licenses constitute the main option of these countries to ensure the provision of affordable drugs. Accordingly, activists have pressed governments of developing countries to issue compulsory licenses, which would set precedents of great legal and political significance for the use and perfection of TRIPS' safeguards and for negotiations with the non-generic pharmaceutical industry.6 The main problem, however, is that even if compulsory licensing becomes a common and widely accepted practice, few developing countries possess or are able to develop in the short-term generic drug industries. Indeed, most of these countries lack the technologies, resources or sufficiently large markets to produce generics cost- effectively. Figure 1 shows the limited manufacturing capabilities of most African countries. As result, the possibility of issuing compulsory licenses does not do much 5 Frederick M. Abbott, "Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the Doha Declaration on Public Health" (Geneva: Occasional Paper 9, Quaker United Nations Office, February 2002), 16. 6 Love, interview. 1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over Pharmaceutical Patent Rights1
André de Mello e Souza Pharmaceutical Industrial Capacity in Africa (1999)
1º Encontro Nacional da ABRI
Política Externa
Global Governance, Developing Countries and Advocacy Networks: The Struggle over Pharmaceutical Patent Rights1
André de Mello e Souza South Africa
South Africa
Cape Verde
Ivory Coas t
Sierra Leone
Central African Republic
1) exclusively imported products
2) local production of finished product (generic, no original modification); imported raw material
3) local contract; manufacture under license
4) local production of finished product and raw material (generic, no original modification)
5) new product (e.g. modification of synthetic pathway, delivery systems, gale nics) with or without local production of raw material
6) new product (novel structure or analogueing) with or without therapeutic innovation
7) new product with nove l chemical and therapeutic gain
Source: MSF, Campaign for Access to Essential Medicines. Moreover, even when faced with the devastation brought about by AIDS, the governments of developing countries are often deterred from issuing compulsory licenses and investing in the production of generic drugs by the United States. Indeed, threats of use of Special 301 retaliatory measures have proven effective in nullifying efforts of developing countries to issue compulsory licenses. For instance, in 1997-1998 the US Trade Representative (USTR), acting on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), threatened to impose sanctions on major Thai exports in reaction to Thailand's plans of issuing a compulsory license for didanosine in order to produce a generic version of this antiretroviral (ARV). Thailand subsequently dropped such plans. Though compulsory licensing "was intended as a lifeline [in TRIPS], in practice any country reaching for this lifeline has been handcuffed by US trade negotiators."7 While the Clinton administration pledged in 1999 not to bully developing nations which resort to compulsory licenses in face of health emergencies, and President Bush has honored such pledge, successor administrations may not do so, especially in light of the continuing use of 301 procedures. Hence, economic coercion still remains a feasible tool for US policymakers. In addition, the USTR of the Bush administration, Robert Zoellick, began to follow a strategy of establishing several bilateral and regional free-trade agreements across the globe.8 Such agreements increase US leverage in pressuring other countries to accept TRIPS-plus IP provisions and usually include arrangements that rule out the production or importation of generics. In effect, though since the year 2000 Brazil has repeatedly offered to transfer to other developing countries, at no cost, the technology and managerial know-how necessary for the production and distribution of high quality low-cost ARVs, thus far none of these countries has taken up the offer. According to Paulo Roberto Teixeira, Coordinator of the Brazilian 7 Karl Vick, "African AIDS Victims Losers of a Drug War" The Washington Post (December 4, 1999). 8 Neil King Jr., "Zoellick Chases Bilateral Pacts That May Complicate Global Goals" The Wall Street Journal (October 25, 2002). National AIDS/STD Program, many developing countries about to accept Brazil's offer were prevented from doing so by their agreements with the US.9 Developing countries unable to produce generic drugs may import them from other countries that have either failed to recognize patents or that have issued compulsory licenses. A research conducted by Oxfam tracked the price of patented brand name drugs in Uganda from May 2000 to April 2002, showing that such prices fell as much as ninety-seven percent after the importation of generics from India began.10 As result, the number of patients taking ARVs at one treatment center alone increased by 200 percent within a year.11 The promotion of the international trade of generics constitutes the main proposal put forth by advocacy networks to solve the problems of access to life-saving drugs of countries that lack pharmaceutical manufacturing capabilities. The international trade of generics also permits the expansion of the global supply of medicines by solving economies of scale problems. Given the small size of the domestic pharmaceutical markets of nearly all actual and potential producers of non-patented low-cost drugs, local production is unworkable in most countries unless part of such production is exported. Indeed, as consumer activist James Love has pointed out, Canada declared in several forums, including the WTO, that its own domestic drug market is too small to allow local manufacturing of drugs. However, Canada ranks tenth among all countries in pharmaceutical market size. It follows that all developing countries — with the possible exception of China and Brazil, which rank eighth and ninth respectively — also lack sufficiently large drug markets to permit local production of generic drugs.12 Because the exportation of medicines expands the markets for local manufacturers, it permits production in countries where such production would be otherwise unviable. Countries such as India, whose share 9 Paulo Roberto Teixeira, interview by author, Brasilia, November 14, 2002. Teixeira is the former Coordinator of the Brazilian National AIDS/STD Program. 10 Prices fell by as much as seventy-eight percent within a couple of months and up to ninety-seven percent over the two years. The largest decreases were for stavudine. A forty mg monthly dose fell from US$ 173 in May 2000 to twenty-three US dollars in February 2001 and then eventually to six US dollars in April 2002. Oxfam, "Generic Competition, Price and Access to Medicines: The Case of Antiretrovirals in Uganda" Briefing Paper No. 26, www.oxfaminternational.org. 11 Oxfam, "Generic Competition, Price and Access to Medicines." 12 James Love, e-mail message on file with author. of the global drugs market is smaller than that of Canada, can maintain their local generic industry by selling drugs to other countries. Thus, exportation permits the maintenance of existing drug suppliers, and opens the way for new ones to emerge. Yet, the limitations of trading generics across national borders are likewise related to restrictions imposed by TRIPS. As discussed earlier, after the expiration of the deadlines established by the agreement for the compliance of parties that are developing countries or LDCs, these countries will hardly be able to avoid observing pharmaceutical patents in their legislations, and compulsory licenses will consequently become their main weapon to combat patent abuses and ensure cheap supply of drugs. However, Article 31(f) of the TRIPS agreement only allows signatories to issue compulsory licenses for the purpose of supplying "predominantly" their domestic markets.13 It follows that the exportation of compulsory licensed medicines by countries that possess a generic drug industry to needy countries that do not is largely restricted by the agreement. Hence, in the long- term the possibilities of LDCs that lack drug productive capabilities resorting to manufacturers of low-cost generics to ensure their provision of affordable medicines would become considerably limited. Uganda, for instance, would no longer be able to continue importing cheap non-patented versions of new anti-AIDS drugs from 13 TRIPS agreement. Activists have pointed out that the definition of "predominantly" is unclear. The European Union has argued, for instance, that article 31(f) does not prohibit exports of compulsory licensed drugs within trade unions. James Love's presentation at the WHO meeting in Harare, August 21, 2001. 3) Empowering Developing Countries: Transnational Advocacy in Multilateral The limitations imposed by TRIPS on the production and trade of generics highlights the importance of institutions of global governance to an issue as important as public health. It is hence not surprising that transnational advocacy networks have operated in multilateral venues so as to attempt to change these institutions. By setting international agendas as well as recreating and modifying the rules and practices of international organizations, they have changed the broader ideational context within which specific political struggles take place. Indeed, while as recently as five years ago "practically nobody was talking about using ARV therapies in poor countries, today, it is rare to find a meeting of international leaders where this idea is not discussed."14 Significantly, the issue of access to essential medicines in the developing world also dominated meetings in international organizations that do not operate primarily or exclusively in the area of health, such as the WTO and several UN agencies and forums. Moreover, the outcomes of many international events provide evidence of deeper ideational change, manifested in the placing of public health as a priority in IP discussions. Discussions in international forums over IP rights and public health have involved intense confrontation between advocacy networks and the US government. It is significant that developing countries became increasingly mobilized and assertive in IP debates. Graham Dutfield speaks about a "shift in the balance of power at the WTO" and notes that "developing countries have begun not only to complain in an organized fashion about TRIPS, but also to make proposals in a coordinated way. Thus, not only have developing countries actively opposed the raising of IPR [intellectual property rights] standards, but they have even proposed that TRIPS be revised in order to circumscribe certain rights, to maintain or even expand the exceptions, and to create new IPR frameworks."15 14 Rosenberg 28. 15 Graham Dutfield, "Introduction" in Trading in Knowledge: Development Perspectives on TRIPS, Trade and Sustainability, eds. Christophe Bellmann, Graham Dutfield and Ricardo Meléndez-Ortiz (London: Earthscan, 2003), 13. Drahos has similarly observed that "during the TRIPS negotiations international NGOs and African states were not significant players. The two most striking features in terms of actors involved in the post-TRIPS scene have been the engagement of international NGOs in TRIPS issues and the leadership of the Africa group on health and biodiversity issues."16 The more prominent roles played by NGOs and developing countries were related rather than coincidental. Here I discuss the most significant of the multilateral events dealing with the issue of access to essential medicines in poor countries. 3.1) The World Health Assembly and the WTO Ministerial Meeting in Seattle In January 1998, upon a request by Timothy Stamps, Zimbabwe's Minister of Health, to Bas van der Heide of Health Action International (HAI), HAI and the Consumer Project on Technology (CPTech) began a joint effort to elaborate a "Revised Drug Strategy" for the World Health Assembly (WHA), which is organized periodically by the WHO in Geneva. The 2002 Doha Declaration owes much to this early effort. HAI and CPTech worked collaboratively on short notice — they had only twelve hours — to produce a draft resolution intended to provide guidance to developing countries. In this draft resolution the two NGOs incorporated language used against the FTAA IP provisions, advocating compulsory licensing and parallel importing,17 and emphasized the importance of access to medicines and the priority of public health over business concerns.18 In so doing, they openly recommended that developing countries adopt the very practices the non-generic drug industry had been attempting to repress through the USTR. The resolution "urges member states to ensure that public health rather than commercial interests have primacy in pharmaceutical and health policies and to review their options under the Agreement 16 Peter Drahos, "Developing Countries and International Intellectual Property Standard-Setting" The Journal of World Intellectual Property 5 (September, 2002): 780. 17 "Parallel imports are goods brought into a country without the authorization of the patent, trademark, or copyright holder after those goods were placed legitimately into circulation elsewhere." Keith E. Maskus and Mohamed Lahouel, "Competition Policy and Intellectual Property Rights in Developing Countries" The World Economy 4 (2000): 605. The practice of parallel importation is based on the principle of international exhaustion of IP rights. When the national exhaustion of IP rights prevails, parallel trade is outlawed. 18 Sell, "TRIPS and the Access to Medicines Campaign," 504. on Trade Related Aspects of Intellectual Property Rights to safeguard access to essential drugs."19 The WHO's Executive Board approved the resolution only because the US was not on the rotating Executive Board that year.20 However, PhRMA reacted vehemently against the proposed drug strategy and mobilized the American government in opposition to the resolution. As Love remarked, the "US put a huge interagency SWAT team together to oppose the resolution."21 A week before the WHA meeting of May 1998, HAI and CPTech organized a conference in Washington, D. C. on the issue of health care, IP rights and international trade agreements. Though the USTR and the FDA refused to participate, the Department of State, the NIH and other federal agencies did participate.22 This conference helped prepare negotiators for the deliberations to follow in Geneva.23 The US sent trade negotiators to the WHA even though this was a public health forum.24 During the meeting Olive Shisana, Director-General of the South African Department of Health, displayed extensive evidence of US engagement in compulsory licensing practices.25 Informed by CPTech and other NGOs, Shisana also showed knowledge of the terms from the US Federal Register and the US statutes allowing compulsory licensing. This move unmasked a purported hypocrisy of the US position toward South Africa's Medicines Act by revealing that the American government attempted to deny other countries a right that it has itself long exercised in defense of its own national interests. "The USTR representatives had been briefed by PhRMA and were caught off guard, ‘blind sided completely', by Shisana's presentation."26 www.cptech.org/ip/health/who/resolution.html. 20 Sell, "TRIPS and the Access to Medicines Campaign," 504. 21 Cited in Sell, "TRIPS and the Access to Medicines Campaign," 505. 22 CPTech, "Time-line of Disputes over Compulsory Licensing and Parallel Importation in South Africa." 23 Love, interview. 24 Teixeira, interview; Sell, "TRIPS and the Access to Medicines Campaign," 505. 25 Love, interview. For US compulsory licensing practices see James Love and Michael Palmedo, "Examples of Compulsory Licensing of Intellectual Property in the United States" (September 29, 2001) available online at www.cptech.org/ip/health/cl/us-cl.html. 26 Sell, "TRIPS and the Access to Medicines Campaign," 505. In October 1998 an ad hoc working group met to discuss the WHA's Revised Drug Strategy. Bitter discussions ensued, with the US representing PhRMA's views in opposition to South Africa, which led countries favorable to a stronger public health statement. At that occasion the WHO was asked to become involved in trade disputes involving pharmaceuticals and health policies.27 In January 1999, the WHA Executive Board met and approved the revised drug strategy. In May 1999, the WHA unanimously enacted resolution WHA52.19,28 which urges member states to assure equitable access to essential medicines as their highest priority and to fully explore to the options available under TRIPS to safeguard such access.29 According to Dr. Ian Roberts, special advisor to the Minister of Health in South Africa, "the main importance of this resolution is that health now has a role in all international trade and finance agreements."30 Also in 1999, PhRMA became outraged by a document in which two WHO officials, Pascale Boulet and German Velasquez, explicitly defended compulsory licensing as a means to extend access to medicines.31 This document implied that the WHO would support the breach of the monopoly of patents when providing technical assistance to developing countries. The organization received threatening letters from the USPTO, the WTO and PhRMA. In response, the WHO convoked a group of specialists that included Reichman and that supported Velasquez, saving his job.32 That same year, on the eve of the Ministerial Meeting of the WTO in Seattle, NGOs issued the Amsterdam statement, which called on WTO members to create a working group on access to essential medicines, support the use of compulsory licensing of patents under Article 31, permit exceptions to patent rights under Article 30 for the international trade of generics and avoid excessively narrow interpretations of Article 39 on test data protection. The Amsterdam statement also called for 27 CPTech, "Time-line of Disputes over Compulsory Licensing and Parallel Importation." 28 www.who.int/gb/EB_WHA/PDF/WHA52/e19.pdf. 29 MSF, HAI and CPTech, "An Open Letter to WTO Member States" (November 8, 1999), available online at www.msf.org/advocacy/accessmed/wto/reports/1999/letter. 30 Cited in HAI, MSF, CPTech, "Countries Grant World Health Organization New Mandate" Press Release (May 29, 1999) available online at http://lists.essential.org/pharm-policy/msg00095.html. 31 German Velasquez and Pascale Boulet, Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement (Geneva: WHO, 1999). 32 Reichman, interview. funding for R&D for DND as well as for a global treaty on R&D to help rectify the prevailing disparity between private sector rights and obligations under TRIPS.33 Discussions on public health were subsequently introduced into the WTO Seattle Ministerial Meeting. Developing countries proposed to exclude essential medicines from TRIPS' patent protection requirements. The European Union presented a counterproposal which allowed compulsory licensing of medicines in the WHO's essential medicines list, thereby fuelling the debate on compulsory licensing. The Seattle meeting collapsed as demonstrations against globalization mounted, but the issues of access to essential medicines and compulsory licensing were introduced on the TRIPS Council's agenda and would come up again with full force in the following WTO Ministerial meeting in Doha.34 3.2) UN Meetings, the TRIPS Council and the Global Fund Starting in January 10, 2000, the UN Security Council met four times to discuss the security threats posed by AIDS. These meetings marked the first time that the Council has discussed a health issue as a threat to peace and security. Participants have focused on the political instability the epidemic may cause35 and issued a resolution vowing to increase efforts to control it.36 These meetings represented an acknowledgement of AIDS as a problem of global dimensions with important implications for international security. In April 24, 2001 the 57th Session of the UN Human Rights Commission approved Resolution 33/200, which was proposed by Brazilian representatives and classifies the access to medicines as a human right to health. According to this resolution, member countries should adopt legislation "to safeguard access to pharmaceuticals (.) from any limitations by third parties."37 Fifty-two member 33 CPTech, HAI and MSF, Amsterdam Statement to WTO Member States on Access to Medicine, available online at www.cptech.org/ip/health/amsterdamstatement.html. 34 t' Hoen, 34-35. 35 For the statements made by meeting participants see UN Security Council, "Security Council Holds Debate on Impact of AIDS on Peace and Security in Africa" Press Release (January 10, 2000), available online at www.un.org/News/Press/docs/2000/20000110.sc6781.doc.html. 36 UN Security Council, Resolution 1308 (July 17, 2000), available online at http://japan.usembassy.gov/e/p/tp-g047.html. 37 "U.N. Body Calls For More AIDS Meds" The Associated Press (April 23, 2001). countries, including England, voted in favor of the resolution; the United States was the only country that failed to do so, by abstaining. U.S. Ambassador George Moose said the resolution's "over-emphasis on use of pharmaceuticals, no matter how well intentioned, detracts from the more fundamental need for primary prevention" and that it "appeared to question the validity of internationally agreed protections of intellectual property rights."38 Though this resolution is not legally binding, it does lend political support to the struggle for access to medicines in the developing In May of 2001, WHA discussions centered on Brazilian proposals related to anti-AIDS medicines. These proposals called for the recognition of the access to ARVs by AIDS patients as a fundamental human right and of the need to reduce the costs of these drugs. It also called for differential pricing, for the production of generics in poor countries and for the creation of an international fund to help these countries finance projects to combat AIDS. Though they were amended and considerably weakened by the US and the European Union,40 two resolutions resulted from the Brazilian proposals, one on the "Global Response to HIV/AIDS" and another on "WHO Medicines Strategy." These resolutions urged member states to "cooperate constructively in strengthening pharmaceutical policies and practices, including those applicable to generic drugs and intellectual property regimes," to "stimulate the development of drugs for diseases whose burden lies predominantly in poor countries" and to "enhance efforts to study and report on existing and future health implications of international trade agreements." They also speak of the need for "systems for voluntary monitoring drug prices and reporting global drug prices with a view to improving equity in access to essential drugs in health systems."41 According to Dr. Daniel Tarantola, a senior policy advisor to the Director General of the WHO, the new resolution "is a turning point in the perception on the global level 38 Cited in South Centre, "Access to Medication a Human Right" South Bulletin 11, available online at www.southcentre.org/info/southbulletin/bulletin11/bulletin11web-04.htm. 39 Ana Magdalena Horta, "Acesso a Remédios contra AIDS É Direito Humano à Saúde," "Comissão da ONU Declara que Acesso a Medicamento É Direito Humano" Época 154 (April 30, 2001). 40 Health Gap Coalition, "Report on the 54th World Health Assembly" (May 2001), www.cptech.org/ip/health/who/hgapwhareport.html. 41 WHA, "World Health Assembly Endorses WHO'S Strategic Priorities" Press Release (May 22, 2001), available online at www.who.int/inf-pr-2001/en/pr2001WHA-6.html. of what should be done about HIV/AIDS. (…) Previous resolutions recognized prevention as the utmost, sometimes only intervention in responding to HIV. This time we are talking about care as an additional set of interventions."42 Since its approval, the resolutions became a standard rule of the WHO and were sent to the UN In the spring of 2001, Ambassador Boniface Chidyausiku of Zimbabwe requested a special TRIPS Council session on access to medicines. The Quaker United Nations Office in Geneva offered assistance for developing country delegates and several legal scholars, economists and activists provided technical support.43 The June TRIPS session, chaired by Chidyausiku, concentrated on the issue of access to medicines. This session marked the increasing articulation and boldness of developing countries, and especially of the African Group, in IP international forums. A growing consensus that TRIPS should not interfere with the protection of public health gained the support of the European Union.44 Though increasingly isolated, the United States continued to defend the interests of the non-generic drug industry. The TRIPS Council decided to continue deliberations on the adequacy of TRIPS in face of the health needs of developing countries and scheduled future meetings on the issue. At the June meeting the delegation of Brazil drew attention to the country's successful AIDS treatment program, which relies heavily on local generic production.45 At about the same time, Germany's chancellor declared that his country would pressure other wealthy nations to help African countries devastated by AIDS, raising the issue in the meeting of the G-8 which took place in July 2001, in 42 Stephen Pincock, "WHO to Adopt HIV/AIDS Resolution" Reuters (May 18, 2000), available online at http://lists.essential.org/pipermail/pharm-policy/2001-May/001056.html. 43 Among those providing support were legal scholars Correa, Abbott, Reichman, Drahos and activists Love and ‘t Hoen. Sell, "TRIPS and the Access to Medicines Campaign," 512, note 125. 44 The paper submitted by the European Union to the TRIPS Council stated that "the view of the EC and their member States is that the absence of any explicit reference to public health in Article 31 [of the TRIPS agreement] does not prevent WTO Members from invoking public health concerns (…) Article 30 amounts to a recognition that the patent rights contained in Article 28 may need to be adjusted in certain circumstances." "EU Paper" TRIPS: Council Discussion on Access to Medicines (Geneva: WTO, June 20, 2001), 4-5. 45 Stephen Ward "Pharmaceutical Rights under Threat" The Financial Times (June 11, 2001). 46 Ana Magdalena Horta, "Cúpula das Américas Diz que AIDS É Ameaça à Segurança" Época 154 (April 30, 2001). Still in June 2001, for the first time in its history the UN General Assembly (UNGASS) convened a special session dedicated to health, and particularly AIDS. Not coincidently, the US withdrew its complaint against Brazil in the WTO during the first day of this session. The discussions at the UNGASS were not restricted to the medical dimension of AIDS. Indeed, on June 27 the special session produced a "Declaration of Commitment on HIV/AIDS" which emphasizes the economic and political threat posed by the epidemic, the human rights of infected people and the need for a balanced HIV/AIDS prevention and treatment strategy as well as for active participation of civil society in the elaboration and implementation of health policies.47 Most importantly, at this occasion UN members called for the creation of a Global Fund to combat AIDS, malaria and tuberculosis in the developing world. The Global Fund is the first of its kind to be administered by representatives of both developed and developing countries, as well as of private donors and NGOs. In addition to giving support to projects elaborated by developing countries, it should help to finance R&D for drugs to treat the neglected diseases of tuberculosis and malaria.48 Within three months the fund's board approved financial support for fifty- eight projects in forty countries over two years, which amounts to US$ 616 million. Further funding commitment will be pending on the performance of programs and resource availability. Following intense negotiation, it was decided that the finances provided by the Global Fund might be used to purchase medicines, including ARVs. Indeed, the fund plans to expand ARV treatment to more than two hundred and twenty thousand people over five years. Much of the expansion is planned for ten countries of Sub- Saharan Africa, including South Africa. Significantly, the Global Fund has also established that the programs it finances should seek to buy the lowest-priced drugs available, whether they are patented or generic. "Until now grantees did not know what to buy because we did not have a policy, but now there is clear advice that they should get the lowest 47 Jennifer Steinhauer, "U.N. Redefines AIDS as Political Issue and Peril to Poor" The New York Times (June 28, 2001); Paulo Roberto Teixeira, e-mail on file with the author. 48 Alan Beattie and David Pilling, "A Fund of High Hopes and Huge Obstacles" Financial Times (June 21, 2001); Melody Petersen, "Bid System Could Be Used for AIDS" Financial Times (June 22, 2001); "Annan: US$ 9 Bi por Ano Podem Salvar o Mundo da AIDS" O Globo (June 25, 2001). possible price", said Anil Soni, a senior official at the fund. Brand-name pharmaceutical companies argued that some generics might not be safe and that the new policy of the fund would encourage greater use of counterfeit medicines. In response, the fund's board recommended that developing countries use the list of drugs approved by the WHO, which includes several ARVs manufactured by the Indian generic industry.49 Still, activists and developing countries fear that the requirement of inflexibly high drug quality and safety standards sanctioned by the WHO will be used politically by the non-generic pharmaceutical industry to restrain the purchase of generics in projects financed by the fund.50 The TRIPS Council convened once more in September 2001, shortly before the Doha Ministerial Conference, as part of the continuing effort to reconcile the agreement with the health needs of WTO member states. At this occasion, Brazil and the African group presented a draft text for a ministerial declaration on TRIPS and public health stressing that nothing in the agreement prevents member countries from responding to public health necessities.51 The US delegation made reference to the study by Amir Attaran and Lee Gillespie-White, which argues that patents do not block access to ARVs in Africa,52 even before it was published to support its position that TRIPS was not impeding access to ARVs in Africa.53 Not coincidently, this study was scheduled to appear 49 Geoff Dyer, "UN-Backed Aids Fund Gives Approval to Generic Drugs" Financial Times (October 12, 2002); Donald G. Mcneil, "U.N. Disease Fund Opens Way to Generics" The New York Times (October 16, 2002) www.nytimes.com/2002/10/16/health/policy/16AIDS.html. 50 Cristina d'Almeida, conversation with author, Rio de Janeiro, December 6, 2002. D'Almeida was a Brazilian representative of the Global Fund's Procurement, Supply and Management Task Force and Intellectual Property Consultant of Far-Manguinhos. 51 ‘t Hoen, 41; Dutfield, 15. 52 Amir Attaran and Lee Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 15 (October 17, 2001): 1886-1892. This paper is an update of an earlier survey by Lee Gillespie-White that found few ARV patents, "Patent Protection and Access to Hiv/Aids Pharmaceuticals in Sub-Saharan Africa, A Report Prepared for the World Intellectual Property Organization (Wipo)" (December 2000), available online at www.wipo.int/about-ip/en/studies/pdf/iipi_hiv.pdf. 53 James Love, "Notes from the US Intervention at the September 19, 2001 TRIPS Council Meeting" IP-Health (October 16, 2001) available online at http://lists.essential.org/pipermail/ip-health/2001-October/002102.html; Francisco Cannabrava, "News from the TRIPS Council on Medicines" IP-Health (October 4, 2001), available online at http://lists.essential.org/pipermail/ip-health/2001-October/001983.html. shortly before the Doha meeting.54 However, since most policymakers involved in the patent and access to medicines debate subscribe to the IP-Health newsletter, they were aware of the research, debate and refutations of activists before the Attaran/Gillespie-White study was published.55 As result, the intended impact of this study was less than PhRMA had hoped it would be.56 These developments underscore the importance of timing for the political use of ideas. While the TRIPS Council session was taking place, the International Federation of Pharmaceutical Manufacturers Association (IFPMA) warned the WTO that weakening IP provisions would produce disastrous consequences for pharmaceutical R&D. Harvey Bale, director-general of IFPMA, declared that drug companies "are not being helped by debates on patents in making decisions on whether to enter into AIDS research. We want to see TRIPS maintained so that industry can keep up the pace of innovation. Investment decisions do depend on the details. Even a political statement can have consequences on these decisions." Accordingly, the IFPMA noted in a statement made available at that time that there has been a thirty percent decline in the number of ARV drug compounds in preclinical and clinical development since 1998, a period that corresponds with "growing attacks on intellectual property rights linked to AIDS medicines." According to that statement, corresponding data for other ARVs in development show no such decline and in fact are increasing. "The attacks against the industry — including the intellectual property foundation of its drug development investments — threaten to discourage new investments by some companies in new AIDS 54 John Donnelly, "Patents Said Not to Cut AIDS Drug Access: Study on Africa Cites Dearth of Global Aid" The Boston Globe (October 17, 2001), available online at http://lists.essential.org/pipermail/ip-health/2001-October/002136.html. 55 See the debate carried out online at http://lists.essential.org/pipermail/ip-health/2001-October/date.html. 56 Sell, "TRIPS and the Access to Medicines Campaign," 515. 57 Daniel Pruzin, "Rewriting TRIPS Could Hurt Research, Pharmaceutical Industry Strongly Warns WTO" WTO Reporter (The Bureau of National Affairs, September 20, 2001), available online at http://www.cptech.org/ip/wto/bna09202001.html. 3.3) The Doha Declaration The TRIPS Council meetings notwithstanding, the health implications of TRIPS were still viewed as a secondary issue in the agenda of the upcoming WTO Ministerial Conference in Doha. Not surprisingly, PhRMA appeared to prefer sidestepping it altogether. On October 23, 2001, Shannon Herzfeld, Senior Vice- President international for PhRMA, addressed reporters at a PhRMA sponsored briefing citing the Attaran and Gillespie-White paper and arguing that the activists' focus on pharmaceutical patents was promoting a "mythology" and that it constituted a "‘distraction' that ‘diverts … important collective resources and energies away from the hard task ahead of us,' which she identified as upgrading the health systems in developing countries."58 Nevertheless, the pressure of developing countries and activists ensured the inclusion of the issue of access to essential medicines in the agenda of the negotiations to follow.59 At the opening of the Doha Ministerial Conference in November 2001, Michael Moore, WTO Director-General, announced that this issue "could be a deal-breaker for a new trade round."60 Remarkably, it dominated the subsequent discussions and received much coverage from the media.61 Crucial in enhancing the position of developing countries were the anthrax infections and the threats of biological terror which followed the September 11 attacks on the United States. Many Americans who manipulated mail stained with the anthrax bacteria contracted disease, and some of them died. Preoccupied with the accessibility of Ciproflaxin, an antibiotic used to treat anthrax supplied by the German company Bayer, Canada threatened to compulsory license this drug and manufacture a generic version of it locally. For a moment, the United States also contemplated issuing a compulsory license of Ciproflaxin, which was defended by 58 Chris Rugaber, "WTO Should Address Tariff Issues, Not Patents, Pharmaceutical Group Says" International Trade Daily (Bureau of National Affairs, October 24, 2001), available online at www.cptech.org/ip/wto/doha/bna10242001.html. 59 José Marcos Nogueira Viana, interview by author, Brasilia, July 18, 2002; Nogueira Vianna is a diplomat who worked for the Brazilian Ministry of Health. 60 t' Hoen 45. 61 Frances Williams, "Patents Hurdle Tops Agenda at Doha Talks" Financial Times (November 14, 2002). Senator Charles Schumer and even Secretary Thompson.62 In the end, both Canada and the United States obtained large discounts from Bayer and renounced compulsory licensing the antibiotic. Advocacy networks and developing country representatives used this occurrence to expose an alleged hypocrisy of the United States. They pointed out that while anthrax caused just a couple of deaths and that the risks of biological terror remained largely uncertain, the US had considered it a national emergency warranting the use of compulsory license. Yet, the US attempted in several instances to refuse this same prerogative to developing countries that have been suffering thousands of avertable deaths from AIDS on a daily basis. The duplicity was not lost on the press, and in particular a New York Times editorial expressed sharp criticism of the US government's policy of preventing developing countries from taking the very measures it had taken to address much more devastating public health crises.63 Likewise, at the Doha meeting the Brazilian Minister of Health, José Serra, opened his speech denouncing this purported double standard of the American government, and stressed that Brazil had been using precisely the same strategy the US used with respect to Ciproflaxin — namely, threatening to compulsory license patented drugs so as to reduce their prices — in order to keep its AIDS treatment program affordable. The USTR replied that if Thompson or the US Congress had contemplated breaking the antibiotic's patent, it would have done so in accordance with TRIPS, paying Bayer compensation. It also stressed that the flexibilities afforded by the agreement are not limited to the United States, but are available to all other WTO members.64 Nonetheless, the fact that the US and Canada seriously considered compulsory 62 Daniel Pruzin, "WTO Talks on TRIPS, Public Health Declaration Stall Over Compromise Text" International www.cptech.org/ip/wto/doha/bna10242001.html. See also Doug Palmer, "Anthrax Spotlights U.S. Stand http://lists.essential.org/pipermail/ip-health/2001-October/002279.html. 63 "The Urgency of Cheaper Drugs" The New York Times (October 31, 2001), available online at http://lists.essential.org/pipermail/ip-health/2001-October/002313.html. 64 USTR, "TRIPS and Health Emergencies" Background Paper (November 10, 2001), available online at www.ustr.gov/Document_Library/Press_Releases/2001/November/TRIPs_Health_Emergencies.html. licensing Ciproflaxin added much credence to the argumentation of developing country representatives.65 In Doha, a group of eighty developing countries, led by Brazil, India and the African Group, proposed a Declaration on the TRIPS Agreement and Public Health, with the aim of securing an interpretation of TRIPS that ensures worldwide access to essential medicines. The declaration would allow those countries to respond to public health needs without being prosecuted by other WTO members. The United States and Switzerland rejected the declaration on the grounds that patents are not a barrier preventing access to essential medicines.66 The United States delegation made several attempts to co-opt a subgroup of African states and thereby break the cohesion of the developing country coalition. The American strategy was to attempt to isolate Brazil and India, countries that were leading the negotiations of this coalition. In informal talks preceding the negotiations, US representatives put forth a proposal extending the transition periods for pharmaceuticals for LDCs, and offering a moratorium on "WTO settlement of TRIPS disputes involving Sub-Saharan African countries and measures taken by them to address the AIDS pandemic."67 If the targeted African states accepted the proposals, the US government could surely veto the broader coalition proposal, excluding Asian and Latin American states as well as eighteen African states, many of which had generic drug industries and sizeable domestic markets. INGOs and developing country officials denounced these proposals as attempts to undermine the unity of the developing country bloc.68 Ultimately, however, the developing country coalition remained united. NGO representatives had been busy working behind the scenes throughout the entire conference. Many prominent participants of the negotiations acknowledged the important role they played, both in keeping this coalition together and enhancing its negotiation powers as well as in pressuring the developed countries. Drahos wrote that "there is little doubt that the rise in influence of the Africa Group has been 65 Sell, "TRIPS and the Access to Medicines Campaign," 515-516; Nogueira Viana, interview; Teixeira, interview. 66 Pruzin. 67 Pruzin. 68 Sell, "TRIPS and the Access to Medicines Campaign," 516; Nogueira Viana, interview. enabled by a partnership with NGOs from civil society."69 Similarly, Paul Blustein wrote for The Washington Post that "The issue of drug patents was one on which activists and developing countries saw nearly eye-to-eye, and they worked together very effectively, with protesters in the United States and Europe pounding on their governments to show less support for the drug companies and more sympathy for AIDS victims. [The Doha] declaration showed how potent the alliance between the activists and developing countries can be."70 Even PhRMA's president at the time, Harvey Bale Jr., acknowledged that business groups like his were facing a different situation from the 1970s and 1980s, when Bale was a US trade official and the GATT was much more dominated than it is today by the QUAD powers: the United States, the European Union, Japan and Canada. Now, Bale declared, developing countries are "banding together despite their differences and showing a greater readiness to use their muscle in the WTO. (…) That gives the activists fertile ground."71 Remarkably, the declaration signed in Doha reproduced in its paragraph 4 almost word for word the main plea contained in the draft text previously submitted by developing countries, stating that "We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Member's right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose."72 In addition, Paragraph 6 of the declaration issued in Doha states the following: 69 Drahos, "Developing Countries and International Intellectual Property Standard-Setting," 781. 70 Paul Blustein, "Getting WTO's Attention Activists, Developing Nations Make Gains" The Washington Post (November 16, 2001), available online at http://lists.essential.org/pipermail/ip-health/2001-November/002429.html. 71 Cited in Blustein. 72 WTO, Declaration on the TRIPS Agreement and Public Health. The only amendment made to the draft text of this paragraph submitted by developing countries was the part which reiterates member's commitment to TRIPS, a demand of the United States, and which replaces "nothing in the TRIPS Agreement" by "the TRIPS Agreement does not and should not." Nogueira Viana, interview. "We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002."73 Though the deadline established by this paragraph was not met, it paved the way for further negotiations to allow countries that issue compulsory licenses on badly needed drugs to supply those drugs to other countries unable to produce their own. The declaration has thus advanced in increasing the flexibilization of TRIPS rules (and particularly of its Article 31(f)). Finally, LDCs have been conceded an extension until 2016 to implement TRIPS. The declaration approved in Doha will, as a matter of law, guide future interpretations of the TRIPS agreement. The pharmaceutical industry was therefore unsurprisingly incensed by the outcome of the Doha Conference. PhRMA was particularly upset that TRIPS and public health were addressed in a separate declaration, as it believed that removing these issues from the broader ministerial declaration elevated their status.74 In the last day of the meeting, November 13, PhRMA wrote a letter to USTR Zoellick denouncing that the declaration was unacceptable and that by allowing it to pass the United States was "selling out the drug industry."75 However, at that point much more than TRIPS was at stake. Given the fiasco of the previous Ministerial Conference in Seattle, the strength of the WTO itself and of the international trade regime it supports would be threatened if negotiations in Doha ended in stalemate. The fragile agreement reached in the meeting could be easily disrupted, and important developing countries such as India were only too eager to take advantage of any pretext at hand to bring the WTO into disrepute. The Doha Conference had already been extended from four to five days, and the US itself had not only signed the declaration but also persuaded Japan and Switzerland to do the same.76 Most importantly, in an ingenious move to lock in its then agreed version, the approved 73 WTO, Declaration on the TRIPS Agreement and Public Health (Doha: November 14, 2001), Paragraph 6. 74 Rugaber. 75 Nogueira Viana, interview. 76 Nogueira Viana, interview. declaration had already been announced to the press, making a reversal even less conceivable. Brazil and INGOs such as MSF warned the US of the costs involved in turning back under such circumstances.77 In this context, the Mexican mediator showed himself unwilling to reopen negotiations, and the American delegation also did not wish to risk it all by trying to amend the declaration on PhRMA's behalf, a move that would undoubtedly provoke vigorous reaction, lead to deadlock and serve to further denigrate the image of the WTO.78 Doha's declaration represents perhaps the most important achievement of the developing countries and their allies in the movement for access to essential medicines. Surely, the meeting also left some important aspirations of this movement unfulfilled. First, developing countries were unable to obtain US support for a legally binding declaration. Second, paragraph 6 of the declaration left one of the crucial issues in the negotiations unresolved, namely, the use of compulsory licensing by countries that lack manufacturing capabilities. Developing countries hoped to reach an agreement to use Article 30 of TRIPS, which permits WTO members to establish "reasonable" exceptions to conferred patent rights, or Article 31(k), which exempts members from Article 31(f) obligations,79 to export compulsory licensed generics to countries unable to produce them. As Love noted, "the negotiation over the export of medicines provisions in the TRIPS will be the next battleground in terms of trade policy."80 Still, an overall assessment of the meeting was undoubtedly positive. As Daniel Berman of MSF noted, "since Seattle there has been a seismic shift. Two years ago many developing countries felt they were powerless against the will of the wealthy countries and their drug companies."81 Similarly, t' Hoen also called attention to the fact that, "the text that has been agreed upon now was unthinkable 6 months, 6 weeks, even 6 days ago."82 Indeed, the outcomes of the Doha negotiations constitute evidence of the ability of developing countries and advocacy networks to 77 Teixeira, interview. 78 Nogueira Viana, interview. 79 The US has used Article 31(k) extensively. 80 James Love, "Views on the Draft Declaration on the TRIPS Agreement and Public Health" (November 13, 2001), available online at www.focusweb.org/publications/2001/views-on-draft-declaration-on-trips-and-health.html. 81 Cited in Love, "Views on the Draft Declaration of the TRIPS Agreement and Public Health." 82 Cited in Love, "Views on the Draft Declaration of the TRIPS Agreement and Public Health." reframe IP issues, partially restore the balance between public and private interests in TRIPS and thereby impact the politics of pharmaceutical patent rights. The TRIPS Council failed to achieve a solution to the problem of access to essential medicines in countries lacking generic production capabilities by the paragraph 6 deadline of 2002. In the so-called mini-Ministerial Meeting held in Sidney during the end of 2002 and other such meetings an impasse emerged. On the one side, the United States and the pharmaceutical multinationals accepted the international trade of compulsory licensed drugs only for a limited number of pre- determined diseases and importing and exporting countries. They also wished to ban generic exports from developing to developed countries. On the other, developing countries and INGOs decried that these proposals would in fact represent a retreat on agreements that had been painstakingly reached in the Doha Declaration and insisted that the possibilities of trading such drugs across borders remain unrestricted and open-ended, so that any country in need be allowed to import any compulsory licensed drug, regardless of which disease the drug treats or where it is produced.83 Finally, on August 30, 2003 a temporary agreement was reached according to which "the obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s)" provided that certain conditions are met. These conditions include the notification of the TRIPS Council, the clear identification of the licensed product (so as to prevent re-exportation), and the limitation of the amount manufactured under the license to that necessary to meet the needs of the eligible importing country. Royalties should be paid in the exporting country taking into account the economic value to the importing country of the use of 83 James Love, Letter to WTO's TRIPS Negotiators Regarding New Chairman's December 16, 2002 Text www.cptech.org/ip/wto/p6/cptech12162002.html; CPTech, Oxfam, MSF and HAI, Letter to WTO Delegates Regarding December 16, 2002 Chairman's Text for "Solution" to Paragraph 6 of the Doha Declaration on TRIPS and Public Health, December 19, 2002, available online at www.cptech.org/ip/wto/p6/ngos12192002.html. the licensed product.84 While many activists were unsatisfied with the conditions imposed on the international trade of compulsory licensed drugs, the governments of several developing countries including the African Group and Brazil viewed it as an important step to promote global access to generics.85 In any case, this temporary agreement should lead to an amendment of TRIPS in the near future.86 84 WTO, "Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health" www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm. 85 Act Up Paris, CPTech, HAI, Health Gap, MSF, Oxfam International et al., Joint NGO Statement on TRIPS and Public Health WTO Deal on Medicines: A "Gift" Bound in Red Tape (September 10, 2003); "Pobres Terão Genéricos Contra Aids" A Tarde (Salvador, August 31, 2003); "Interesse do País foi Resguardado, Diz Embaixador" O Estado de São Paulo (São Paulo, August 31, 2003). 86 Duncan Matthews, "From the August 30, 2003 WTO Decision to the December 6, 2005 Agreement on an Amendment to TRIPS: Improving Access to Medicines in Developing Countries?" Intellectual Property Quarterly 2 (2006): 91-130. 4) Conclusions Transnational advocacy networks have used ideas strategically and empowered developing countries in multilateral IP negotiations. However, since these networks lack the financial resources and access to policymaking circles enjoyed by businesses, they have relied primarily on the use of "moral leverage" through the dissemination and tactful presentation of new ideas and through Activists have resorted to shaming and used information to expose purported hypocrisies and double-standards involved in patent disputes. The power of information is exercised not only through the way it is presented or packaged, that is to say, through framing, but also through its strategic use in political settings. Shaming is effective when the leverage of information is enhanced by its forceful use, by its presentation in contexts where it cannot be easily dismissed or ignored, and where its implications are significant. Shaming has been a widely used strategy in multilateral settings. For instance, the revealing of US compulsory licensing practices in the WHA caught the American delegation by surprise and weakened its opposition for such practices in other countries. Likewise, US plans to compulsory license Bayer's ciproflaxin in order to respond to increasingly frequent anthrax attacks were widely discussed during the WTO Doha Meeting and reinforced the claimed prerogative of developing countries to also make use of compulsory licensing in order to confront their health emergencies, and most notably AIDS. 87 Sell and Aseem Prakash argue that businesses and NGOs cannot be distinguished on the basis of their strategies or objectives, since these actors are both normative and instrumental. However, I believe the authors overstate their case by not paying sufficient attention to the different kinds of resources, power and consequently strategies that are employed by businesses and NGOs. While businesses have more financial resources and may adopt lobbying, advertising and donations as strategies, NGOs rely mostly on protestation, shaming and persuasion. I agree with the authors that both businesses and NGOs use ideas strategically, but whereas the former also relies heavily on coercion, the latter rely solely on information and argumentation. NGOs are also in a better position to use norms because their objectives are perceived as being more legitimate than profit-seeking businesses in the eyes of the general public. See Susan K. Sell and Aseem Prakash, "Using Ideas Strategically: The Contest Between Business and NGO Networks in Intellectual Property Rights" International Studies Quarterly 1 (March 2004): 143-176. At the multilateral level, transnational advocacy networks have played a key role in introducing health concerns into IP negotiations and in advising and supporting developing countries, which were previously all but silent in such negotiations. A diverse number of international forums were used, some of which are not primarily concerned with health or IP. These forums served to set new agendas as well as to legitimize and institutionalize an alternative conception of trade, IP, and health rights. The Doha Declaration represents the most significant of these, and the negotiation process that led to it reveals the unprecedented assertiveness and cohesion of developing countries as well as the decisive importance of the network of activists working behind the scenes. Even if specific to pharmaceuticals and public health emergencies, the regime change that has been brought about by the Doha Declaration - and especially the amendment of TRIPS - is surprising in light of the fact that it goes against the declared interests of the most powerful state. These institutional changes suggest that non-state actors can influence global political outcomes and governance structures and that they can do so solely by organizing and using ideas strategically. In so doing, the case on patents and access to medicines also points to the limitations of mainstream international relations theoretical approaches that are state-centric and rationalist and that focus exclusively on material power.88 Moreover, it also calls attention to the distributive and political nature of international regimes and challenges dominant functional analyses of these regimes.89 Finally, the case also highlights the difference that agency makes and the need for agential explanations of political change. Such explanations enable a more adequate consideration of the mutual relationship between agency and structure that characterizes structuration,90 and thereby also shed light on the origins and dynamics of international norms and ideational structures. 88 See, for instance, Stephen D. Krasner, "State Power and the Structure of International Trade" World Politics 3 (April, 1976): 317-347; Susan Strange, "Cave! Hic Dragones: A Critique of Regime Analysis" in International Regimes, ed. Stephen D. Krasner (Ithaca, N.Y.: Cornell University Press, 1983), 338 and Stephen D. Krasner, "Global Communications and National Power: Life on the Pareto Frontier" World Politics 43 (April 1991). 89 After Hegemony: Cooperation and Discord in the World Political Economy (Princeton, N.J.: Princeton University Press, 1984). 90 Alexander Wendt, "The Agent-Structure Problem in International Relations Theory" International Organization 3 (Summer 1987); John Ruggie, "What Makes the World Hang Together? Neo- Utilitarianism and the Social Constructivist Challenge" International Organization 4 (Autumn 1998): 375-376. For the origins of the concept of structuration, see Anthony Giddens, Central Problems in Social Theory (Berkeley, Calif.: University of California Press, 1979) and The Constitution of Society: Outline of the Theory of Structuration (Cambridge: Polity Press, 1984).

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