In this paper, Noah Novogrodsky argues that NGOs need to rethink the way they promote access to medicines.  Rather than serving solely as advisors to certain developing countries engaged in multilateral negotiations, NGOs should embrace their role as idea generators, as advocates within developed states and as independent actors capable of challenging corporations.

Introduction

Access to advanced medicines is increasingly dictated by the Trade and Related Intellectual Property Agreement (TRIPS), a central pillar of the World Trade Organization (WTO).  An agreement by and of sovereign states, TRIPS serves to globalize intellectual property rights (IPRs) that were historically granted under domestic law for the territory of a particular state.  And while those rights are not absolute, the few mechanisms recognized by the TRIPS agreement for evading the force of patent protection - compulsory licensing and parallel importing - generally require state action.  Similarly, the World Health Organization is populated by member states, and the recently convened Intergovernmental Working Group meetings on Public Health, Innovation and Intellectual Property (IGWG) represents another instantiation of sovereign country debates regarding global health and access to medicines.[1]

States, however, are only part of the story.  With ever greater frequency, non-state and supra-state actors are defining the struggle for access to medicines, most commonly anti-retroviral drugs (ARVs) used to combat HIV/AIDS.  NGOs, including the Treatment Action Campaign, Knowledge Ecology International, ACT-UP and Médecins Sans Frontières (MSF, also known as Doctors Without Borders) have revolutionized advocacy, on the national and international stage.  Brand and generic pharmaceutical manufacturers have come to play an increased role in the development of global rules and incentives for production.  Large philanthropic foundations, specifically the Bill and Melinda Gates Foundation[2] and the William Jefferson Clinton Foundation,[3] have promoted bulk purchasing, preferential pricing and the rollout of ARVs to developing countries and communities in need.  (Although the Gates Foundation dwarfs the budget of many developing states, it is not formally accountable to any entity save its own charitable status).  Many large research universities, themselves the recipients of public funding, are engaged in multifaceted licensing agreements.  And the Global Fund for AIDS, Malaria and Tuberculosis, for its part, operates as a public-private partnership.  In turn, the Global Fund is championed by Jeffrey Sachs, Bono and other celebrity supporters of the RED campaign, advisors and advocates perhaps, but otherwise quintessentially non-governmental actors.

This paper examines the role of certain non-state actors in the struggle to increase access to essential medicines.[4]  As an illustration of that effort, I rely on the global campaign (usually spearheaded by national or sub-national NGOs) to ensure that people living with HIV/AIDS (PLWHA) obtain ARVs. [5]  The pathogenic threat posed by AIDS exceeds the interest or capacity of any single state and thus serves as a fertile example of the power contained in transstate organizations, corporations, networks and funding mechanisms.[6]

The first part of this paper explores the traditional role of NGOs in combating AIDS, identifies some of the costs associated with outsider roles claimed or assigned to non-state actors in the creation of IPR rules and contrasts that status with the insider position of many corporate interests at WTO negotiations.  Part two of the paper examines the relationship between non-state actors and state delegations (particularly from the global south) at TRIPS deliberations.  The final section probes some of the alternative roles available to NGOs and recasts non-state actors as a central force in the fight to bring life-saving medicines to people in need.

Absent at the Inception

In the beginning, NGOs were conspicuously absent from the debates surrounding the creation of global IP mechanisms.  Indeed, although individual academics[7] and representatives of some developing nations[8] raised alarm at the TRIPS Agreement, fashioned as part of the 1994 Uruguay Round compacts, negotiators from states of the global north (generally knowledge-based industry exporters) succeeded in narrowing the gaps in domestic systems and ensuring that minimum levels of IP protection existed in the domestic laws of all WTO member states.[9]  Before TRIPS, approximately 50 states excluded pharmaceutical products from patent protection.  Despite the concern that the extension of patent protection would lead to higher pharmaceutical prices (particularly in states that historically had not patented medicines), virtually all developing states accepted TRIPS as part of the package of Uruguay Round agreements, including WTO provisions that promised greater access to developed state markets in textiles and agricultural goods.[10]  The incorporation of uniform IP protections into the fabric of the global trading system continued through a series of bilateral free-trade agreements including many that incorporate additional (TRIPS-plus) provisions that enable patent holders to extend or evergreen their monopoly rights beyond the 20 years dictated by TRIPS or which impede competition through data exclusivity provisions or restrictions on the use of compulsory licenses.

Where were civil society groups in this period?  They were, as Douglas Webb details, busy becoming service providers for treatment, education and prevention services.[11]  In Haiti, for example, the NGO Partners in Health revolutionized AIDS service delivery by training community health workers called "accompagnateurs" to distribute ARVs, supervise home-based therapy and ensure adequate feeding.[12] Following the creation of PEPFAR in 2003, church groups and other religious organization joined established international NGOs in a scramble to extend AIDS programming.[13]  In many countries, civil society organizations trained their attention on national leaders and the enormous challenge of persuading sometimes recalcitrant leaders to adopt laws, policies and practices to assist PLWHA.[14]

By contrast, well-financed corporations played a prominent role in the development of TRIPS.[15]  Industry groups created a trade committee to forge a common agenda that united Hollywood producers, the chemical and pharmaceutical industries, publishing interests and the software sector.  As Amy Kapczinski explains, "Part of how they united and gained the support of plicymakers was by forging a common identity as "intellectual property" industries, by articulating their collective centrality to the U.S. economy, and by framing the use of their products without permission as ‘theft.'"[16]No company was more influential in lobbying U.S. trade negotiators that Pfizer and no CEO more committed to linking trade and IPRs than Pfizer's Chief, Edmund Pratt.  Using his network of established business contacts, Pratt used industry gatherings and high-level meetings to communicate the importance to his firm of linking trade and patent protections.[17]  Pratt also headed the Advisory Committee on Trade Negotiations, through which private sector representatives gained direct access to the U.S. Trade Representative.

In short, transnational corporations - non-state actors with a unique pedigree - leveraged their relationship with state officials to shape trade law and influence the robust expansion of IPRs into previously unreached markets.  At a time of accelerated globalization, the lobbying of a single pharmaceutical company with substantial investments in the developing world generated an outsized effect. 

There is, of course, nothing new about the ties between well-financed industries, lobbyists and policy.  What is novel is the exposure of corporate influence and the increased understanding of corporations, foundations and NGOs as equal units of analysis in the world of international trade and human rights.  The dynamic of Health Gap and ACT-UP organizing a boycott of Abbott or Ira Magaziner's effort on behalf of the Clinton Foundation to persuade pharmaceutical companies to provide voluntary licenses to generic companies making ARVs suggests that state parties no longer enjoy a monopoly in the ordering of international trade terms and intellectual property governance. 

Advocacy Through Proxies

It is no exaggeration to say that civil society groups examining TRIPS after 1994 found a fully-formed institutionalized, multilateral, and comprehensive mechanism for addressing intellectual property-related issues and disputes that itself was wholly embedded within a framework of international trade.  Compared to preexisting instruments, the TRIPS Agreement contains a complete provision on enforcement and imposes detailed obligations on states.  The TRIPS Agreement "also establishes a strong monitoring and supervisory scheme through the machinery of the TRIPS Council, a marked departure from the norm of previous conventions."[18]  Within TRIPS, compliance and enforcement questions are addressed through the WTO dispute resolution system, a scheme that ensures a permanent, quasi-judicial state-centric dispute resolution mechanism.  Generic manufacturers, NGOs and foundations prepared to promote enhanced access to essential medicines are marginalized (we might say ‘erased') within the TRIPS arrangement.  Instead, a global compact by and among sovereign states serves to "freeze the comparative advantages"[19] that ensure Northern technological supremacy and counter Northern countries' declining competitive position in the global market (particularly vis-à-vis labour costs).

In view of the statist composition of the new international IP regime, it is unsurprising that many prominent NGOs sought to partner with sympathetic state parties to the WTO in order to enhance access to medicines.  Brazilian and South African advocates, collaborating with international human rights organizations, urged their respective governments to use TRIPS flexibilities, particularly permissible compulsory licensing provisions, to increase the flow of ARVs to combat HIV/AIDS.[20]  The issuance (or threatened issuance) of compulsory licenses in each of these cases engendered intense criticism from patent-holding pharmaceutical companies and their political allies.[21]  In South Africa, thirty-nine multinational pharmaceutical companies challenged the country's 1997 Medicines and Related Substances Control Amendment Act No. 90 (legislation that would have allowed parallel importing, and compulsory licensing while encouraging generic competition); it took a sustained civil society campaign led by the Treatment Action Campaign to persuade the firms to withdraw the action.[22]

By 1999, public health and development NGOs began actively pursuing an international agenda to support developing countries in their efforts to negotiate solutions to the problems that respond to the concerns on the impact of higher prices for patented medicines.  The activities of NGOs raised the profile of the access to medicines debate and provided important succor to developing countries on the eve of the Fourth WTO Ministerial Conference held in Doha in 2001.  MSF,[23] for example, initiated a highly publicized campaign to track drug prices, to advocate for increased generic production of ARVs, and to expose the ways that TRIPS contributes to the neglect of diseases afflicting the poor.[24]

NGOs, particularly MSF, the Consumer Project on Technology (now Knowledge Ecology International) and Health Action International, played a significant role in the processes leading up to the adoption by WTO Members of a Declaration on TRIPS and Public Health at the Doha Conference on 14 November 2001, which, while affirming that "the TRIPS Agreement should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines", and reaffirming "the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose" nonetheless relies entirely on the metric of state parties.  Several NGOs, working with independent journalists, effectively silenced predictable U.S. opposition to expanded compulsory licensing by publicizing the apparent hypocrisy of the U.S. threat to issue a compulsory license to increase the availability of ciprofloxacin to treat anthrax, under the authority of 28 U.S.C. § 1498,[25]while opposing the use of TRIPS flexibilities to scale up ARV therapy in developing countries. 

NGOs also played a crucial role in the subsequent two year period of negotiations on the implementation of the Doha Declaration on TRIPS and Public Health, that led to the adoption on August 30, 2003 of the WTO Decision on the Implementation of the Paragraph 6 of the Doha Declaration.[26] In this period, NGOs worked closely with select countries of the global South (particularly Brazil, India and Thailand) to develop positions related to the Doha talks, to train and educate delegation members and to ensure cohesion among the bloc of developing states.

NGOs have also laboured to take advantage of the August 30, 2003 Decision.  The example of Canada's Access to Medicines Regime (CAMR, also known as Bill C-9) provides a poignant illustration.  Drafted after the 2003 round of World Trade Organization talks in Doha, CAMR amended Canada's Patent Act to promote the export of generic versions of essential medicines, including ARVs, through compulsory licensing.  MSF, and a generic pharmaceutical company quickly applied for a compulsory export license to produce a triple fixed dose combination therapy for HIV and AIDS.  In order to issue the license, however, Canadian officials require a reciprocal import license from a least developed country demonstrating a need for the drug and affirming the state's inability to produce the product itself.  MSF is barred from applying for the import license.  To complete the application process, it appears as if each country that wants MSF to distribute the drug will need to make the appropriate notification to the WTO or the Government of Canada; the NGO may not make the notification on the country's behalf.  To date, only one state has done so and the first successful export of ARVs (from the generic producer Apotex to Rwanda) took five years to negotiate.[27]

At the just concluded Intergovernmental Working Group meetings of the WHO in Geneva- the group moniker clearly identifies who has a seat at the table - NGOs again embraced the role of advisors to sympathetic states.  Although the ranks of civil society groups have swelled and their means of disseminating information have expanded,[28] non-state actors continue to work on the margins of multilateral fora such as the IGWG.[29]  In this capacity, NGOs have named and shamed (including identifying the Colombian delegate by name and detailing his stalling tactics), offered briefing reports, authored op-eds and provided real time accounts of country positions.  Several large NGOs have also provided delegates from developing countries (particularly those from smaller states) with technical assistance, prepared substantive policy inputs and coordinated information-gathering among civil society groups.[30]  All too frequently, U.S., Canadian, Australian and European NGO staffers find themselves criticizing their country of origin in the name of developing states.  As a strategy of reform from within an institution, this technique ensures that the NGO perspective is actively debated.  It nonetheless remains a proxy battle and one that is weighted against the inclusion of non-state actors.

Imagining Alternatives

Should NGOs continue to work through states to reform TRIPS or to expand flexibilities under the agreement?  The absence of civil society representation or developing country perspectives in the original drafting of the TRIPS Agreement (put differently, the capture of the agenda by industry interests in alliance with Northern states) and the modest success of the Doha Round talks suggests that NGOs have a role to play in bolstering the trade delegations of the global South.  Likewise, the attempt to exploit TRIPS flexibilities while brokering generic competition has allowed groups like the Canadian HIV/AIDS Legal Network to test TRIPS-influenced domestic legislation and to monitor and evaluate pragmatic efforts to expand access to medicines.  By participating in the supporting roles assigned to NGOs under CAMR and similar legislative schemes, civil society groups demonstrate their willingness to serve as change agents, however limited the scope of their involvement.

While such work has produced tangible results, NGOs can do more than advise developing country delegations at multilateral trade and IP negotiations.  By embracing their identity as citizen-representatives with standing to submit valuable alternative notions, NGOs can challenge authority and shape the discourse.  I submit that NGOs have at least four distinct roles to play.

First, non-state actors, including academics, are the source and disseminators of desperately needed ideas.  Prize funds,[31] patent pools and alternative registration schemes are powerful ideas that challenge the orthodoxy of institutionalized patent monopolies as the only acceptable model.  The Health Impact Fund proposal, describing a complement to the existing patent regime that would generate a flow of pharmaceutical innovation without depriving the poor of their freedom to buy new medicines at competitive market prices is a crucial counter-narrative to TRIPS-centric incentives.  Academics and access to medicine campaigners have identified existing practices and flexibilities (eg. parallel importing, non-exclusive uses, process rather than product patents) while imagining workable alternatives.  These ideas and their cross fertilization in a variety of fora are every bit as important as the medical innovations protected by TRIPS.

Second, NGOs must redouble efforts to influence developed countries and their negotiating posture.  While TRIPS is likely to frame IPRs for the foreseeable future, vertical advocacy and lobbying has produced tangible results, from President Clinton's overdue announcement at Seattle in 1999 to the Lawyer's Collective's campaign to shape India's 2005 Patent Act.  Advocacy of this nature is rooted in the work of ACT-UP, the Gay Men's Health Crisis and Health Gap, which have sought to break the silence around AIDS by loudly and effectively championing the needs of infected people.[32]  By staging die-ins and appearing in public bound and gagged, activists have created performances that embarrass politicians while demonstrating the link between patents and the need of PLWHA.[33] Of course, the access to medicine movement has also forged political alliances (including unlikely bedfellows Bono and Michael Gerson, Bill Clinton - the citizen, not the President - and Jesse Helms) and employed a wide array of methods to expose the costs of a patent regime that permits of no exceptions.  The desacrilization of IPRs owes as much to the advocacy of Stephen Lewis, Jamie Love, Zackie Achmat, Jeffrey Sachs and many others as it does to formal amendments to TRIPS.  Equally important, NGOs concerned with public health cannot cede domestic influence to the U.S.-based Pharmaceutical Research and Manufacturers Association (PhRMA) and its allies around the globe.  PhRMA's political supporters routinely deride access to medicine campaigners as politically unaccountable.  Charges of this sort require consistent and principled opposition, particularly where the democratic process has broken down (as in South Africa) and where TAC has assumed the additional burden of countering government denialism.[34]

Third, NGOs are only beginning to tap the potential of horizontal advocacy.  Hazel Tau et al v. GlaxoSmith Kline, Boehringer Ingelheim et al,[35] demonstrates the efficacy of direct action by one non-state actor against another in the context of an antitrust suit before South Africa's National Competition Commission.  There, the complainants, working with the Treatment Action Campaign, alleged that the firms had breached Article 8(a) of South Africa's 1998 Competition Act 89 by charging excessive prices for antiretroviral medicines to the detriment of consumers.  "The excessive pricing of ARVs is directly responsible for premature, predictable and avoidable deaths of people living with HIV/AIDS, including both children and adults" the complainants charged.[36]   The Competition Commission found for the complainants, although it allowed the defendants to amortize development costs.[37]

Claims against corporations under domestic law and the use of national patent flexibilities (such as India's opportunity for pre-grant opposition to patent applications or Canada's CAMR export license procedures) offer tested avenues for increasing access to medicines.  In this vein, the challenge to patents (or defense of infringement actions) waged by generic firms or competitors is essential, if not paradigm-shifting, work.  Universities Allied for Essential Medicine (UAEM) offers another example of institutional accountability.  UAEM is an activist organization at 40 universities across the US, and Canada that works to increase access to drugs developed at universities.[38]  The goal of UAEM is to change the licensing practices of universities so that when they are licensing a university discovered drug to a pharmaceutical corporation or biotech company they include provisions that ensure that the drug will be made generically available in the developing world, to increase research in those diseases that affect the developing world and to change the metrics by which universities measure the success of a drug. 

Fourth, NGOs operating in this space are part of a broad movement that has served to politicize the previously arcane field of intellectual property law.  Under the rubric of access to knowledge, "NGOs and activist coalitions that emerged independently of one another to contest the contours of IP rights in seeds, medicines, software, genetic material, and cultural goods, are beginning to build links to one another."[39] The connections among these groups take the form of a network that has allowed its members to create a set of shared principles, arguments, and identities that has introduced a development agenda to WIPO.  Access to medicine campaigners have much in common with open source advocates and creative license proponents.  Solidarity with other advocates pursuing the broad dissemination of knowledge and opportunity will ensure that the access to medicines movement is neither isolated nor exceptional.  Just as corporate actors did in the run up to TRIPS, it is in the interest of NGOs concerned with public health to strengthen the network of relationships and positions formed by other knowledge-based sectors.

Conclusion

NGOs at the forefront of the struggle for affordable and accessible medicines are forcing a reconception of allegiances, values and state-citizen relationships.  In the post-TRIPS era, the alliance with developing countries has allowed access to medicines advocates to participate in multilateral talks by proxy and to introduce alternative perspectives but NGOs still do not have a seat at the table.  This simple fact should persuade advocates that the future of the access to medicines movement will be defined by direct action and the nurturing of new ideas rather than the quality of advice provided to country delegations.

[1] In this respect, the IGWG continues the intergovernmental tradition represented by the ‘3 x 5' initiative, the WHO-led effort to put 3 million people on ARV treatment by the end of 2005.

[2] The Gates Foundation, which declares that it is driven by the view that "all lives - no matter where they are being led - have equal value" has given or pledged nearly $8 billion to global health initiatives, including at least $650 million to the Global Fund.  See Bill and Melinda Gates Foundation: Global Health, http://www.gatesfoundation.org/

[3] Clinton Foundation Programs: HIV/AIDS Initiative, http://www.clintonfoundation.org/cf-pgm-hs-ai-home.htm.  The Foundation has been instrumental in negotiating price reductions and bulk procurement opportunities from pharmaceutical companies.

[4] To be sure, non-state actors are a polyglot group and even among international NGOs, there is a great variety of organizations.  As used here, the term NGO refers to organizations that are in no way connected to governments or international institutions.

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[5]The demand for treatment is often, but not always, represented as a right provided by national law and reinforced by international human rights instruments.  See, e.g., Alicia Yamin, Not Just a Tragedy: Access to Medications as a Right under International Law, 21 B.U. Int'l L.J. 325, 344 (2003); Zita Lazzarini, Access to HIV Drugs: Are we Changing the Two-World Paradigm?, 17 Conn. J. Int'l L. 281, 288 (2002).  The right to treatment of ART is plainly a part of access but the claim is narrower than a demand for access to knowledge or to essential medicines, all of which raise definitional questions that include the concepts "affordability" and "sustainability."  See WHO Policy Perspectives on Medicines - Equitable Access to Essential Medicines: A Framework for Collective Action, available at: ___ Importantly, the struggle for access is not limited to the developing world.  In Abigail Alliance for Better Access to Developmental Drugs v. C. Von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), cert. denied ___ U.S. ___ (2008 WL 114305), the United States Court of Appeals for the District of Columbia held that the Constitution does not provide terminally ill patients with a due process right of access to experimental drugs that have passed limited safety trials but have not yet been proven safe and effective.

[6] See Laurıe Garrett, The Coming Plague (1994); David Fidler, Fighting the Axis of Illness: HIV/AIDS, Human Rights and U.S. Foreign Policy, 17 Harv. Hum. Rts. J. 99 (2004); J. M. Spectar, The Olde Order Crumbleth: HIV-Pestilence as a Security Issue & New Thinking About Core Concepts in International Affairs, 13 Ind. Int'l & Comp. L. Rev. 481 (2003); Noah Benjamin Novogrodsky, The HIV/AIDS Pandemic and Human Security, 100 Am. Soc'y Int'l L. Proc. 345, 349 (2006).

[7] See e.g. Marco C.E.J. Bronckers, The Impact of TRIPS: Intellectual Property Protection in Developing Countries, 31 Common Mkt. L. Rev. 1245 (1994).

[8] This draft contrasts developing countries with developed countries. In the WTO framework, "developing countries" self-identify themselves as such, subject to challenges from other countries. See World Trade Organization, Who are the Developing Countries in the WTO?, http://www.wto.org/english/tratop_e/devel_e/d1who_e.htm. Generally, however, this term refers to poor . . . nations, using criteria based almost exclusively on per capita income.  The . . . countries in this group include states which are variously labeled as developing countries, underdeveloped countries, low-income countries, Majority World, the South or the Third World. These nations generally have low levels of technology, basic living standards and little in the way of an industrial base. Their economies are mainly agricultural and are characterized by cheap, unskilled labour and a scarcity of investment capital. Per capita incomes are below $5000 and often less than $1500. Around 70% of the world's population live in the developing countries, almost all of which are in Africa, Asia, Oceania and Latin America. ANDY CRUMP, THE A TO Z OF WORLD DEVELOPMENT 78-79 (Wayne Ellwood ed., 1998). Within the WTO, "developing countries" are contrasted to "least developed countries."

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[9] Margaret Chon, Intellectual Property and the Development Divide, 27 Cardozo L. Rev. 2813 (200_).

[10] Why developing states would make such concessions is a matter of some debate.  Many accounts point to the lack of personnel in attendance at the Uruguay Round of talks as well as the failure of trained trade lawyers working on behalf of states in the global south.  Several NGOs have since emerged in an attempt to remedy the gulf between developed and developing country delegations, including ILEAP (International Lawyers and Economics Against Poverty) which provides support to developing country delegations in WTO negotiations.  See www.ileap-jeicp.org/index.html.

[11] See Douglas Webb, The Political Economy of AIDS in Africa in The African State and the AIDS Crisis (Amy Patterson ed., 2005).  (Webb argues that there are at least three reasons for the outsized role of NGOs as AIDS service providers in Africa.  "Firstly, the rise of NGOs has been in direct response to the inaction or neglect of the state where a clear mandate to act has been dismissed.  Secondly, NGO proliferation has been in response to the absence or limited nature of government credibility with its own constituency, leaving a vacuum of representation at local levels.  Finally, and more rarely, governments have encouraged NGO activities in HIV/AIDS.")

[12] Paul Farmer, From "Marvelous Momentum" to Health Care for All, 86 Foreign Affairs 155, 156 (2007).

[13] Helen Epstein, The Invisible Cure:  Africa, the West, and the Fight Against AIDS (2007).

[14] Raymond A. Smith & Patricia D. Siplon, Drugs Into Bodies (2006)

[15] See Peter Drahos, Global Property Rights in Information: The Story of TRIPS at the GATT, 13 Prometheus, 1, 12-13 (June 1995).

[16] Amy Kapczinski, The Access to Knowledge Mobilization and the New Politics of Intellectual Property, ___ Yale L.J. ___ (2008)

[17]  See Peter Drahos, Expanding Intellectual Property's Empire: The Role of FTA's (2003).

[18] Uche Ewelukwa, Patent Wars in the Valley of the Shadow of Death: The Pharmaceutical Industry, Ethics and Global Trade, 59 U. Miami L. Rev. 203, 213 (2005).

[19] Carlos M. Correa, Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options (2000).

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[20] See João Biehl, Will to Live: AIDS Therapies and the Politics of Survival 2007 (arguing that Brazil's AIDS policy is emblematic of novel forms of state action on and toward public health).

[21] See e.g. AIDS Access Foundation et al. v. Bristol Myers-Squibb Company and Department of Intellectual Property, Central Intellectual Property & International Trade Court, Black Case No. Tor Por 34/2544, Red Case No. 92/2545 (Thailand 2002); Lisa Forman, "Incentivizing Justice: Linking Human Rights, Trade and Access to Medicines" in MCIS Briefings (Comparative Porgram on Health and Society Lupina Foundation Working Papers Series 2005-2006 (cataloguing the pressure applied to Thailand, Mexico, Chile, Brazil, Indonesia, Bolivia, Colombia, Ecuador, Peru, Venezuela, South Korea and South Africa as they considered compulsory licensing).

[22] Pharmaceutical Manufacturers' Association and 41 Others v. President of South Africa and 9 Others, High Court of South Africa, Transvaal Provincial Division, Case No. 4183/98 (2001).

[23] MSF treats more than 72,000 people with ARVs in 19 different countries.

[24] See Ellen F.M. t'Hoen, TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond, 3 Chi. J. Int'l L. 27 (2002).

[25] Sen. Chuck Schumer, Press Release, New Cipro Source Could Dramatically Increase Supply (16 Oct 2001) www.senate.gov/~schumer/SchumerWebsite/pressroom/press_releases/PR00728.html.

[26] The August 30 Decision sets out the mechanism to allow countries with insufficient or no pharmaceutical manufacturing capacities to import generic versions of essential medicines from a foreign generic producer.

[27] Apotex recently indicated that the legislation is so cumbersome that it does not intend to seek additional export licenses under CAMR.

[28] Bloggers and posters to the IP-Health list serve provided hourly accounts of activities at the IGWG negotiations.

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[29] For some NGOs at international conferences, being relegated to the hallway is literally unbearable; at the Rome Conference that created the International Criminal Court, Richard Dicker of Human Rights Watch took Somalia's country placard (knowing that Somalia had sent no one to the conference) and used it to gain entry to the direct negotiations.

[30] Duncan Matthews, The Role of International NGOs in the Intellectual Property Policy-Making and Norm-Setting Activities of Multilateral Institutions, 82 Chi.-Kent L. Rev. 1369 (2007).

[31] James Love, Patent Prizes, __ Chi.-Kent L Rev. __ (2008)

[32] See JG Twomey Jr. AIDS activism, Hastıngs Cent. Rep. 39 (1990).

[33] ACT-UP and other groups also offered a blueprint for performative activism that has been appropriated and rearticulated by the Treatment Action Campaign and other groups advocating for economic, social and cultural rights today.  See Lucie White and Louis A. Horvitz, "Stones of Hope:  African Lawyers Reclaim Human Rights to Challenge Global Poverty" (2008).

[34] See William Forbath, The "Transformative Constitution": Treatment Action Campaign and the Politics of Social Rights in South Africa (working paper).

[35] Hazel Tau & Others v. GlaxoSmith Kline and Boehringer Ingelheim, Competition Commission of South Africa (2003).

[36] Id.

[37] The Commission's decision promoted a settlement between the parties under which GlaxoSmithKline and Boehringer Ingelheim agreed to grant voluntary licenses on their patented medicines to generic firms in exchange for a royalty.  The AIDS Law Project, acting on behalf of the Treatment Action Campaign, recently filed another complaint with the South African Competition Commission to investigate the refusal by Merck and its South African subsidiary to allow sufficient competition to lower the price of efavirenz.

[38] The movement started in 2001 at Yale when students realized that the drug, d4t, essential for treating AIDS/HIV was discovered at Yale by Dr. Prusoff but was licensed out to BMS and was being sold for $1600 per patient year - a price no patient in Africa could afford.  Students mobilized and asked the University to leverage its power to lower the price, but the University resisted.  Students continued to pressure the University and BMS and after a front page story in the NYT by Dr. Prusoff, BMS agreed to at cost pricing in Africa.  A few months later, BMS agreed to allow generic competition which led to a price of $55 per patient year.

[39] Amy Kapczinski, Access to Knowledge, ___ Yale L. J. at ___.

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