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Law, Politics, and Access to Essential Medicines in Developing Countries
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This article argues that to advance the struggle for access to essential medicines,it is necessary to identify the global and local regimes that shape the rules that giveimpetus to particular policy options, while undermining others. In exploring therole of law and politics in this process, the author first outlines the globalization ofa standardized, corporate-inspired, intellectual property regime. Second, theauthor uses the example of the HIV/AIDS pandemic to demonstrate how the stabil-ity of this new regime came under pressure, both locally and globally. Finally, it isargued that while the global HIV/AIDS pandemic and the social movements thatemerged in response to government inaction have effectively challenged the TRIPSregime, this complex contestation has reached an unsustainable stalemate in whichdevelopment aid, corporate, and non-governmental philanthropy is simultaneouslyproviding increased availability to drugs while precluding a more lasting solutionto the crisis of access to essential medicines in developing countries. Keywords:
globalization; intellectual property; trade; medicines; HIV/AIDS *This article is part of a special issue of Politics & Society on the topic, “Between the Washington Consensus andAnother World: Interrogating United States Hegemony and Alternative Visions.” The papers were initiallypresented at a mini-conference organized in conjunction with the American Sociological Association meetings inAugust 2007. For more on the theme, please see the Introduction to this issue. POLITICS & SOCIETY, Vol. 36 No. 2, June 2008 207-246DOI: 10.1177/0032329208316568 2008 Sage Publications Life-saving pharmaceuticals represent a symbolic paradox; they are, at the same time, a mark of extraordinary scientific progress and a demonstration of anabysmal lack of social solidarity at the beginning of the twenty-first century. Themodern pharmaceutical industry is dominated by multinational corporations,1committed to maintaining control over the products they produce, while assert-ing that this control best guarantees a future flow of miracle cures. Consumers ofpharmaceutical products are by contrast quintessentially diffuse, both in terms oftheir needs and in the structure of the drug market, which involves a complex pat-tern of patented and generic medicines, public and private purchasers, as well asdirect marketing and market creation by the major producers.2 The regulatoryregime is equally complex, involving both national regulatory agencies as well asinternational organizations and less formal processes of harmonization, resis-tance, and accommodation. The debates and struggles over access to essentialmedicines thus provide a unique lens into this globalized system of production,consumption, and governance. Essential medicines represent a direct challenge to the existing pharmaceutical regime. The idea of essential medicines was first introduced in the late 1970s whenthe World Health Organization (WHO) adopted the twin ideas of “essential drugsand national drug polic[ies]”3 and established the Essential Drugs and MedicinesPolicy, Health Technology and Pharmaceuticals Cluster within the WHO. In broadterms, this strategy emerged in the context of the push by developing countries fora new international economic order. The essential medicines program operates in abimodal fashion: on the one hand, there is the creation of an international modellist of essential drugs, and on the other hand, the program gives direct assistance tonational health ministries, who formulate national drug polices and local essentialdrugs lists together with standard treatment guidelines. The aim of the program isto provide access to essential medicines by ensuring the rational selection of drugsat affordable prices so that funding may be sustainable and a reliable supply ofmedicines guaranteed within any particular national health system.4 Given the mul-tifaceted goals of this program, including the rational use of drugs on the one handand sustainable access through the adoption of the cheapest available products onthe other hand, the model list was for a long time limited to generic products—i.e.,medicines that were off-patent. This pattern was broken with the eleventh editionof the WHO Model List of Essential Drugs in 1999, which, for the first time,included a number of “patented pharmaceuticals which are important drugs fortreatment of HIV/AIDS and AIDS-related opportunistic infections.”5 The question of sustainable access to affordable medicines is no more evident than in the context of the HIV/AIDS pandemic. Despite a global HIV/AIDS crisisthat has been described as the “defining humanitarian catastrophe of our time,”6it is the availability of anti-retroviral drugs that shapes the impact this pandemicis having on different societies. Availability has transformed the pandemic indeveloped countries into a chronic manageable disease, while in developing countries over three million people continue to suffer AIDS-related deaths everyyear. In developing countries, the ability of governments to effectively combatthe pandemic remains captive to an ongoing struggle over intellectual propertyrights in the global economy. Thus, after twenty years and over 20 million deaths,the question of AIDS is no longer purely a problem of medical science, but increas-ingly a question of social and political struggles. With an estimated 33.2 millionHIV-positive people in the world,7 the pandemic poses a potentially destabilizingthreat to both individual communities and society more generally. Yet the existenceof a medical regime that allows HIV-positive individuals to live extended and pro-ductive lives has transformed the very nature of this pandemic. This transformationhas generated a transnational social movement and raised important questionsabout the relationship between domestic demands for social and economic justiceand international claims of property rights and economic freedom.8 While patents are not the sole reason why developing countries have failed to adequately respond to the pandemic, it is only access to anti-retroviral medi-cines that will enable countries to respond to this crisis in an effective way.
Similarly, as in the case of other diseases, the availability of pharmaceuticals isonly one aspect of a comprehensive health system needed in any country, but itis an element that grew in significance as well as cost over the course of thetwentieth century. Advances in the understanding of diseases, the biological sci-ences, and in chemistry produced three distinct pharmaceutical revolutions overthe course of the twentieth century.9 These breakthroughs have transformed thefield of medical practice, and modern pharmaceuticals now play a central partin addressing humanities disease burdens. In the case of HIV/AIDS, it is theavailability of new life-saving drugs that enhances efforts to encourage peopleto engage in voluntary testing and preventive behaviors. It is the combination ofa viable medicines regime linked to testing and preventive education that pro-vides the greatest opportunity to undermine the social stigma and denial that isfueling this pandemic in many parts of the world.
Although the idea of essential medicines and the related struggle over patents is not limited to the global effort to address the HIV/AIDS pandemic, it is con-flicts over access to anti-retroviral medicines (ARVs) and drugs to treat AIDS-related opportunistic infections that provide a unique lens through which we mayexplore the broader legal and political issues of globalization, self-determination,economic development, and health in developing countries. South Africa repre-sents in this context a complex case combining an overwhelming HIV/AIDSpandemic with a range of legal and political responses that include the emer-gence of a new social movement organized around access to treatment; a gov-ernmental response that has interlaced an enormous amount of denial with oftenprogressive interventions in international fora; and internal political and policyconflicts that have led to the adoption of the most ambitious public sector treat-ment plan in the world, but also public statements and bureaucratic meddling that has hampered the implementation of this program.10 In comparison to Brazil,India, and Thailand, who have also played significant roles in the global debatesand conflicts over access to medicines, South Africa’s nascent pharmaceuticalindustry faced an entrenched patent law and did not have the capacity to eitherproduce the active ingredients for ARVs, reverse engineer-patented drugs, ormanufacture these drugs for a market large enough to produce the economies ofscale necessary to bring the cost of individual dozes within an affordable range.
Furthermore, South Africa became an early target of both the multinational phar-maceutical corporations and the United States government, which was aggres-sively asserting the need to protect patent rights, particularly of the brand-namecompanies, and attempting to impose even higher standards of patent protectionthan those adopted within the international trade regime after 1994. It was onlywith the advent of voluntary licenses, the availability of international aid fund-ing, and an effective reprieve from U.S. political and trade pressure, that SouthAfrican pharmaceutical manufacturers have begun to produce ARVs. This article argues that to understand this terrain, upon which struggles for access to medicines continue to be waged, it is necessary to identify the globaland local regimes and struggles that shape the rules that give impetus to particu-lar policy options while undermining others. In exploring the role of law and pol-itics in this process, I will first outline the globalization of a standardized,corporate-inspired, intellectual property regime. Second, the article will use theexample of the struggle for access to medicines in the context of South Africa’sHIV/AIDS pandemic to demonstrate how the stability of this new regime cameunder pressure, both locally and globally. Third, the article will explore the ter-rain of international institutions and domestic politics within which these differ-ent initiatives and struggles are played out. The purpose of this exploration is toidentify how various interests were able to exploit the specific form and interac-tion of the related international regimes—that regulate different aspects of thedevelopment, production and distribution of health-related goods—to facilitateparticular outcomes. Finally, I will argue that although the global HIV/AIDSpandemic and the social movements that emerged in response to governmentalinaction have effectively mobilized a range of resources—both non-governmentaland from within governments—to challenge the Trade Related IntellectualProperty Rights (TRIPS) regime, this complex contestation has reached an unsus-tainable stalemate in which development aid, corporate, and non-governmentalphilanthropy is simultaneously providing increased availability while precludinga more lasting solution to the crisis of access to essential medicines. From thesearguments, I conclude that there are important lessons for activists and socialmovements as well as developing countries and will suggest ways to improvesustainable access to essential medicines in an era in which the link betweenpublic health and economic development has been clearly established. TRIPS AND THE CHANGING PLACE OF PHARMACEUTICALS Today it is assumed that intellectual property and pharmaceutical patents in particular are issues of international trade law. Yet before the agreement onTRIPS was signed at Marakesh in April 1994, as part of the new World TradeOrganization (WTO) agreements, it was commonly understood that questions ofpatent protection were a matter of national sovereignty and controlled by domes-tic law. Historically, there was not even a general notion of intellectual property;instead, there was a clear distinction drawn between patent rights, consideredindustrial property, and other forms of intellectual property, such as copyrightand trademarks, understood as author’s rights or commercial property.11 Separateinternational agreements—the Paris and Berne Conventions—addressed thesedifferent areas of law and focused on the idea of national treatment, whichrequired participants in the particular international regime to provide the samerights and protections for the intellectual property rights of foreigners as theyprovided to their own citizens. Neither of these international regimes establishedminimum standards, nor even required a participating country to offer any rightsat all for intellectual property claimants within their jurisdiction.12 Even where there were strong legal traditions protecting intellectual property rights, the recognition of rights in pharmaceuticals was often subject to specialtreatment. Many countries treated medicines as public goods and either did notgrant patent protection to pharmaceuticals at all or limited intellectual propertyprotection to the processes by which the particular products were produced. Infact, before the issue was put on the agenda at the Uruguay Round of trade talksin 1986, approximately forty states did not issue product patents for pharmaceu-ticals, leading in some countries to a proliferation of copies of patented drugs.
Despite the adoption in 1970 of the Patent Cooperation Treaty by members of theWorld Intellectual Property Organization (WIPO), increasing that organization’scapacity to promote the protection of intellectual property by providing technicalsupport services to national patent offices, the pharmaceutical industry continuedto complain about commercial losses they attributed to the weakness of patentprotection, particularly in newly industrializing countries. For the pharmaceuti-cal industry, the goal thus became the establishment of a minimum standard ofpatent protection allowing the increasingly multinational corporations that dom-inate the industry to operate in a single global market.
In pursuit of this goal, corporate leaders in the United States devised a strategy bringing together the pharmaceutical corporations and other intellectual propertyintensive industries—including the computer and entertainment industries—withthe purpose of improving “intellectual property protection internationally untilAmerican standards became the international norm, especially in developingcountries.”13 According to Philip Ellsworth, a corporate leader and ex-chairman ofthe International Organizations and Issues Committee of the PharmaceuticalManufacturers Association in the United States, the industry pursued three avenues in its effort to achieve greater patent protection.14 First, a multilateralresponse aimed at the international organizations, WIPO and the GeneralAgreement on Tariffs and Trade (GATT). Second, a bilateral response, underwhich the U.S. government put pressure on trading partners to improve intellec-tual property protection in their domestic laws. Third, a unilateral approach, push-ing for changes in U.S. law that both enabled and required the United States TradeRepresentative to monitor the level of intellectual property protection grantedin countries around the world and to take action—in the form of unilateralsanctions—when the intellectual property rights of U.S. citizens were not beingadequately protected.15 While this tripartite strategy may not have been con-sciously devised as a single strategy, the effect of working simultaneously at thenational, bilateral, and multilateral levels did produce a global result. Over time, these efforts involved a number of distinct steps. The earliest efforts saw Pfizer—one of the largest manufacturers of pharmaceuticals—attempt to obtain reform of the Paris Convention through WIPO. Developingcountry resistance to higher intellectual property standards was however empow-ered in this particular forum by WIPO’s governance rules, which provided for aone-nation, one-vote decision-making procedure. When this attempt to achievereform from within WIPO was frustrated, Pfizer began to work with other multi-nationals, such as IBM, through the GATT Advisory Committee on Trade Policyand Negotiation. This committee had been established under the 1974 Trade Actas a result of domestic pressure in the United States and with the goal of institu-tionalizing business input into U.S. trade policy and multilateral negotiations.
The impact was to emphasize the need for trade negotiations to “go beyondpurely trade policy matters and focus on obstacles to investment.”16 It was thisshift that began to reframe intellectual property protection as an issue of freetrade with vast “implications for innovation, economic development, the futurelocation of industry, and the global division of labour.”17 The domestic effort was led by Pfizer, which worked with the Pharmaceutical Manufacturers Association to lobby Congress, the executive branch, and espe-cially the Office of the U.S. Trade Representative (USTR) to promote increasedprotection for intellectual property rights abroad. The success of this campaign isreflected in two distinct but complementary United States government initiatives.
First, the USTR agreed to “expend the considerable diplomatic effort needed toput intellectual property on the GATT Uruguay Round agenda.”18 Then, when theUruguay Round began in 1986, Pfizer’s Chief Executive and the Chairman ofIBM established the Intellectual Property Committee to coordinate the policy ofintellectual property-based corporations in the negotiations.19 Second, Congressamended the Trade Act three times, in 1979, 1984, and 1988, increasing the powerof the United States Trade Representative to take retaliatory action against coun-tries seen as engaging in “unfair” trade practices, even if the sanctions imposedwould violate the existing international obligations of the United States.20 An important aspect of the new law was the inclusion of formal procedures through which private parties could petition the USTR to vindicate the claims ofU.S. citizens. Furthermore, the 1988 amendments included two statutory provisions,now popularly referred to as Special 301 and Super 301, which were particularly far-reaching. While Super 301 “required the US Trade Representative to identify andinitiate Section 301 actions against foreign countries that used unfair trade practiceto inhibit US trade,”21 Special 301 requires the USTR, “on a yearly basis, to identifyand initiate Section 301 actions against foreign counties that deny adequate andeffective protection of intellectual property rights to US persons and products.”22The power of Special 301 lies in the requirement that the USTR monitor and reportannually on all foreign intellectual property laws and practices, and in the “fast-track” system, which requires the USTR to decide on what retaliatory action to takewithin six months. In this way, the corporations managed to use the law to bring thevast resources of the U.S. government to bear on their particular concerns. This ledin practice to the creation of both a “priority watch list” and a “watch list,” whichtogether are used to pressure countries into negotiating with the USTR to increasethe levels of protection their domestic laws give to intellectual property.
Success for this strategy was first achieved in Korea—which at the time had one of the most sophisticated domestic pharmaceutical industries in the develop-ing world—where the government was persuaded in 1987 to adopt both patentand pipeline protection, i.e., providing protection for existing inventions before apatent is formally granted for pharmaceuticals.23 Continuing this strategy of bilat-eral pressure, the USTR began in 1991 to take up a series of cases aimed at coun-tries that boasted burgeoning domestic pharmaceutical manufacturing industries,most of which relied on reverse engineering to produce cheap forms of drugs ini-tially developed in more industrialized countries. The first of these cases chal-lenged Thailand’s intellectual property regime. Despite U.S. acknowledgment thatit was demanding higher standards than required under the existing internationalstandards, Thailand revised its patent law in February 1992 to comply with thesedemands. In May 1991, the USTR also initiated an investigation of India’s intel-lectual property laws, focusing particularly on the failure of Indian law to protectpharmaceutical products and its broad involuntary licensing provisions. AfterIndia refused to accede to U.S. demands, President Clinton partially suspendedIndia’s duty free treatment under the General System of Preferences, withdrawing$80 million in benefits on exports. This pressure coincided with India’s oppositionin the ongoing Uruguay Round trade talks to the U.S. proposal to make intellec-tual property protection part of the trade agreement.
The demise of compulsory licensing in Canada provides another example of the interrelationship between bilateral negotiations and the construction of mul-tilateral regimes. Under a compulsory license, the government allows identifiedparties to either produce or import a patented product without the permission ofthe patent holder, thus limiting the monopoly power usually enjoyed by the patent owner. Under Canadian law, pharmaceuticals were not covered by theregular patent provisions; rather, generic firms were able to apply to the gov-ernment for a license to manufacture or import a pharmaceutical product undercompulsory license provided that they paid a royalty of 4 percent to the patentholder.24 However, even Canada did not always have the economies of scaleneeded to manufacture affordable medicines, and so the compulsory licensingprovisions were changed in the late 1960s so that there was no longer a “require-ment that the drug be manufactured in Canada.”25 Instead the generic companiescould use the compulsory license to import medicines produced elsewhere, thusincreasing the number of competitors in the market and dramatically reducingthe price of the medicine. While only twenty-two compulsory licenses weregranted for the domestic manufacture of on-patent drugs between 1923 and1969, there was a dramatic increase in the use of compulsory licenses after1970, with 142 “issued on 47 prescription drugs” between 1970 and 1978.26 Referring to this situation, U.S. corporate leader and pharmaceutical repre- sentative Philip Ellsworth described Canada as a problem, because Canadians,he argued, have a womb to tomb mentality and “Canada has a Third Worldmindset.”27 Canada was in fact targeted by the pharmaceutical industry not onlyfor its domestic policies, but also as a potential model for other countriesattempting to provide greater access to essential medicines. As RobertSherwood, a U.S. expert on intellectual property law told a free trade conferenceorganized by the University of Toronto’s Centre for International Studies inNovember 1991, the Pharmaceutical Manufacturer’s Association was pushingthe Bush Administration to achieve in the negotiations for the North AmericanFree Trade Association (NAFTA) what it had failed to obtain in the earlier FreeTrade Agreement with Canada. The issue, according to Sherwood, “was not somuch Canada but the fact that developing countries were ‘using Canada as anexample to justify compulsory licensing as a means to achieve lower prescription-drug prices.’”28 In fact the Bush Administration “made eliminating the Canadianlaw a condition for concluding” NAFTA.29 The United States negotiators in the NAFTA negotiations on intellectual property had two basic aims: to prohibit discrimination among fields of tech-nology, thus precluding a special regime for pharmaceuticals; and to narrow theconditions under which it would be permissible to adopt compulsory licensing.30Responding to this pressure, the Canadian government conducted aPharmaceutical Review in 1991, which concluded that competitive patent pro-tection was needed to attract new investment and to encourage research anddevelopment. Significantly, the Canadian pharmaceutical industry, while not inthe first level of integrated firms—engaged in research and development(R&D), manufacture, and distribution—did have innovative capacity and so hadelements within it who considered this an opportunity for their own expansion.
The Canadian government decided, however, not to merely accept U.S. demands,but rather to internationalize the bilateral negotiations by supporting the Dunkel Text—the package of proposals for resolving the Uruguay Round distributed inDecember 1991 by Arthur Dunkel, GATT’s director-general. Dunkel’s draft textaddressed points of disagreement among the parties, and while providing com-promise proposals to questions such as the “level and nature of IP [intellectualproperty] afterward protection,” the “grace periods” that would be granted todeveloping countries, and the institutional framework for dispute resolution andimplementation, he suggested that the draft be “accepted or rejected as a whole.”31By demanding that NAFTA reflect the Dunkel proposals, Canada could endorsefull patent protection for pharmaceuticals, but could also avoid U.S. demandsrestricting parallel imports that were left for national determination by theTRIPS Agreement. Parallel importation is premised on the idea of patentexhaustion, which holds that once the patent owner has sold the product in anymarket, the buyer may resell it without permission, even in another market inwhich the product is patented. The idea of patent exhaustion limits the ability ofpatent holders to set vastly different prices in neighboring markets as long asbuyers are able to import the product into the parallel market. NAFTA in factignores the issue and leaves it to the parties to ban parallel imports through theirown domestic legislation, if they so wish.32 In response to NAFTA, Canada adopted legislation in February 1993 abol- ishing the special regime for compulsory licensing for pharmaceuticals, provid-ing instead for full patent protection for applications filed in Canada on or afterOctober 1, 1989.33 This law, however, also gave the Patented Medicines PricesReview Board (PMPRB) the power to order fines and to lower prices of patentedmedicines. As the WTO noted in its Trade Policy Review of Canada in 1998,“the guidelines issued by the PMPRB limit prices of most new patented drugsto the range of prices for existing drugs used in the treatment of the samedisease; to the median of the prices charged for the drug in other industrializedcountries and to increases in the consumer price index (for patented drugsalready on the market).”34 Although the Canadian scheme remains contested—involving at least two decisions by the WTO panel in 2000—Canada has thusfar managed to slow the rise of domestic drug prices and resist accepting theTRIPS-plus standards of total patent protection demanded by the U.S. government.
While the conclusion of the NAFTA negotiations saw the intellectual prop- erty issues closely tied to the advancement of the Uruguay Round negotiationsin the form of the Dunkel Draft, in most cases the pressure to increase intellec-tual property protection arose as a result of direct pressure from the UnitedStates government and representatives of industry. In some cases, such as Chilein the early 1990s, the United States-based pharmaceutical industry played adirect role through its trade association—the Pharmaceutical ManufacturersAssociation—in shaping the domestic patent regime.35 As a result of these inter-ventions, through bilateral trade deals and direct economic and political pres-sure, a number of newly industrialized countries—those most likely to have the capacity to sustain a domestic pharmaceutical industry—had already acceptedhigher standards of intellectual property protection than had been historicallyrequired under international standards. This process effectively softened theground for the ongoing negotiations within the Uruguay Round so that resis-tance to the inclusion and expansion of intellectual property standards as part ofthe global trade deal leading to the creation of the WTO was limited to a num-ber of holdout countries—primarily Argentina, Brazil, and India.36 Transforming the International Legal Regime GoverningIntellectual Property and Trade Although intellectual property rights (IPRs) were raised for the first time in the context of international trade negotiations at the 1982 ministerial meeting ofthe GATT, it would take until 1986 before IPRs would be a formal part of theUruguay Round agenda. While the linking of intellectual property and tradeissues may be traced to structural and legal changes affecting patents and intel-lectual property more generally within the United States—including the role oftechnology, deregulation, and the creation of the patent court in 198237—it wasthe Canadian Proposal in October 1990 “that the new Multilateral TradeOrganization (MTO) should be acceded to as a single undertaking,”38 that set thestage for the successful integration of intellectual property rights into the inter-national trade regime. Although some developing nations and newly industrial-ized countries objected to the inclusion of intellectual property as part of thesubject matter of negotiations,39 it was this change in the format of negotiationsthat sealed the outcome of these already contentious debates. Previously, underthe GATT, each tariff reduction or other measure aimed at reducing barriers tointernational trade would be individually negotiated and countries could agreeto be party to different elements of the GATT without being bound by all its pro-visions. This method of negotiating accorded with long-standing principles ofinternational treaty-making, in which different states could become party to aparticular agreement, yet file reservations as to particular aspects of the agree-ment in which they chose not to be bound. The outcome was a patchwork ofcommitments in which the particular rights and commitments of each statedepended upon its acceptance of the different elements of the treaty. Althoughit has been accepted that a state’s reservation from any treaty provision is notvalid if it attempts to avoid the central goal of the treaty—such as arose in thelitigation over reservations to the genocide treaty—the GATT allowed parties toagree to lower tariffs within particular categories acceptable to each stateaccording to its own estimation of the tradeoffs in costs and benefits to its owneconomy. Negotiating a single package on the basis of a negotiated consensushad the affect of transforming the entire international trade regime. Pushing for consensus and requiring acceptance of the complete package as a condition of membership of the WTO transformed the international trade regime.40 At the same time, this principle enabled powerful parties to introducesubject matter, such as the protection of intellectual property, which was not his-torically within the jurisdiction of the GATT. The emergence of a standardizedand global intellectual property regime is, from this point of view, the productof two related developments: first, the final Uruguay Round package incorpo-rated agreements creating the WTO and its Dispute Settlement Understanding,and second, the eight-year long campaign by the USTR during the period of theUruguay Round, using section 301 of the U.S. Trade Act, to coerce variousdeveloping countries into providing higher protections for intellectual propertyrights within their jurisdictions. Developing countries were left with the choiceof either exiting the international trade regime altogether and thus foregoing thebenefits of “most favored nation treatment” in their bilateral trade relations aswell as the promise of greater market access for agricultural goods in particular,or accepting the inclusion of an intellectual property regime with a transitionalperiod to help them adjust to the rigors of the new regime. In addition, the struc-ture of the negotiations41 and the direct involvement of representatives from theintellectual property intensive industries in the negotiations over the TRIPSagreement itself meant that the concentration of expertise and influenceweighted strongly in favor of the developed countries.42 Even then the U.S.-based pharmaceutical and entertainment industries continued to complain aboutthe outcome—particularly the length of the transition periods granted to devel-oping and less-developed countries.43 Finally, there was little unity amongdeveloping countries, which objected to the inclusion of the TRIPS Agreement,since many of those who would be most immediately affected had already beenpressured into adopting higher standards of domestic IP protection throughbilateral pressures and negotiated agreements with the United States.
Despite their complaints, the minimum standards now recognized under TRIPS represent important gains for the global pharmaceutical industry, includ-ing: an extended period of protection—to twenty years; the requirement that alltechnologies receive equal treatment—precluding lesser protection for pharma-ceuticals; and limits on compulsory licensing. For the brand-name industry,however, this was just the beginning, as they continued to strive for what hasbecome known as TRIPS-plus. These goals include a complete ban on compulsorylicensing and parallel imports, pipeline protection for inventions still underdevelopment, no early registration or stockpiling of generic products prior to thetermination of the patent period, and liberal rules allowing for patent extension.
In addition to these specific patent-related rules, the industry is also advocatingfor stronger data protection rules that would prevent domestic regulatory agen-cies from using data from clinical trials produced for the purpose of registeringa particular patented drug from being used to evaluate the safety and effectivityof a bio-equivalent generic drug. Once again the United States has been using its dominance in bilateral trade negotiations to demand the inclusion of these TRIPS-plus standards in a series of Free Trade Agreements with countries ranging from Jordan to Australia.44The effect is an increasingly homogenized set of intellectual property rulesdesigned to protect and enhance the rights and control of the multi-nationalpharmaceutical corporations over newly discovered drugs and even older med-icines that are found to be effective for different diseases or used in new com-binations or administered by different methods. Control over these resourcesremains the central goal of these private interests. Although it seemed that thecreation of the WTO and the incorporation of intellectual property issues intothe trade regime had transformed and settled the global IP regime, it would notbe long before these assumptions became unsettled. In response to global healthcrises, including the HIV/AIDS pandemic, malaria, and tuberculosis, activistsand developing country governments mounted a sustained campaign to reopenthe debate over patent protection and access to medicines. HIV/AIDS, SOCIAL MOBILIZATION, PHILANTHROPY, Only two years after the adoption of this new trade regime at Marakesh in April 1994, the introduction of life-saving anti-retroviral medicines simultane-ously gave new hope to those engulfed in the pandemic, and raised questionsabout the cost and availability of these new drug regimes. Although many coun-tries had adopted the WHO’s essential drugs program model as a means to pro-vide greater access to medicines for all ailments, it was the fact that these newdrugs were dramatically reducing mortality rates among HIV/AIDS patients indeveloped countries, and would have to be taken for the rest of a patient’s life,that made these medicines the key focus of activists around the world. Thestruggle to guarantee access to these medicines soon unfolded at multiple lev-els: locally, in the form of the Treatment Action Campaign in South Africa andACT UP in the United States; internationally, in the campaigns of internationalnon-government organizations such as MSF and Oxfam; and on the globalstage, as developing country governments pointed to the public health excep-tions in the TRIPS Agreement and demanded recognition of these flexibilitiesthrough the Doha Declaration on Public Health in 2001. The building of a newtransnational solidarity in the face of HIV/AIDS45 transformed the terrain uponwhich the struggle over access to medicines continues, but this effort has alsobeen corralled by the emergence of philanthropic initiatives and strategic licens-ing by the pharmaceutical corporations. At the same time, some developingcountries, such as Brazil and Thailand, have continued to resist attempts toundermine their domestic pharmaceutical industries and have taken advantageof the debate over access to pursue their own industrial strategies around phar-maceutical production. Even South Africa, which has not had a major pharma-ceutical industry, has begun to explore ways in which the changing regime of exceptions for less developed countries and regional procurement might bolsterthe country’s economic ambitions. In the case of South Africa, the early attempt by Nelson Mandela’s govern- ment to increase access to medicines ran into opposition by the pharmaceuticalindustry, but also became a key part of growing resistance to the imposition ofa homogenized patent regime. When Mandela’s government took power in1994, the South African health care system still reflected the impact ofapartheid. Although 80 percent of the population relied on the public health sys-tem for access to “modern” medical treatment, and 60 to 70 percent of pharma-ceuticals (by volume) were consumed in the public sector, the private sectoraccounted for 80 percent of the country’s total expenditure on drugs.46 Inresponse to this situation, the government adopted a new National Drugs Policyin 1996 that incorporated the WHO’s essential medicines program. One yearlater, in 1997, the legislature amended the existing Medicines Act to allow forthe parallel importation of medicines and compulsory licensing, among othermeasures, to implement this agenda. Although the new law was designed inpart to change fundamentally the distribution practices of the pharmaceuticalmanufacturers—prohibiting, for example, industry employees from serving onthe Medicines Control Board, and blocking manufacturers and wholesalers fromproviding bonuses, rebates, or other incentives to doctors—the key features ofthe amendment were the “measures to ensure supply of more affordable medi-cines.”47 These measures included empowering the Minister of Health “to pre-scribe conditions for the supply of more affordable medicines . . . so as toprotect the health of the public . . . notwithstanding anything to the contrary inthe Patents Act”; and to “prescribe the conditions on which any medicine whichis identical in composition, meets the same quality standard and is intended tohave the same propriety name as that of another medicine already registered inthe Republic” may be made available.48 The effect of these provisions wouldhave been to allow the parallel importation of medicines, generic substitutionwithout the consent of the prescriber, and the issuing of compulsory licenses toallow for the importation or local manufacture of medicines without requiringthe approval of the patent owner.
Although the new law passed the South African parliament over the objec- tions of the pharmaceutical industry and the U.S. government, and was signedinto law by President Nelson Mandela in December 1997, implementation ofthe South African Medicines Amendment Act was soon put on hold, and itwould never be implemented in its original form. Led by the PharmaceuticalManufacturers’ Association of South Africa (PMA), forty-two parties, includinglocal companies, subsidiaries of transnational corporations, and the multina-tional corporations themselves, challenged the constitutionality of the 1997 Act.
They made a number of constitutional claims, but argued most specifically thatthe Act’s provisions—empowering the government to determine the extent to which rights granted under a patent in South Africa shall apply, and that allowthe government to prescribe conditions for the supply of more affordable“generic” medicines—deprived owners of intellectual property in the affectedpharmaceutical products of their constitutionally protected property rights. Theclaimants proceeded to engage a number of major private law firms, and gov-ernment attorneys soon found themselves completely snowed under with thevolume of filings and alternative lines of attack.49 Not only did the plaintiffs ini-tiate the litigation with a request for an interim interdict preventing the law frombeing implemented, they soon followed with a series of claims in alternative fora—to the Public Protector and the Competition Board, respectively—challenginggovernment statements about the cost of drugs and calling for an inquiry into analleged anti-competitive attempt by pharmaceutical distributors to create a jointcompany to engage in the parallel importation allowed under the act. The scaleof this legal assault, facilitated by the financial resources of the multi-nationalcorporations involved, was unique in the South African legal context. In a notice of motion filed in the High Court of South Africa (Transvaal Provincial Division) in Pretoria on February 18, 1998, the plaintiffs articulatedan extraordinary array of claims against the Act’s validity. In addition to assert-ing that the Act violated their patent rights, as well as South Africa’s legallyincorporated international obligations under TRIPS, the plaintiffs claimed thatthe powers granted the Minister of Health amounted to an unconstitutional dele-gation of legislative authority to the executive, because it failed to set out policyconsiderations or guidelines that would limit the Minister’s power, and insteadmerely empowered the Minister to discriminate against local manufacturers infavor of imported medicines. Plaintiffs also charged that various sections of theAmendment were unconstitutional as they violated the basic values and princi-ples governing public administration. At the same time, M. T. Deeb, the chiefexecutive officer of the Pharmaceutical Manufacturers Association, argued in herfounding affidavit that section 15C is in conflict with the TRIPS Agreement andwent so far as to claim that “Parliament ought not to have made a law which isin conflict with South Africa’s international obligations.”50 In effect, she invertedthe traditional claim that equal and sovereign states are only bound by their ownconsent to international obligations and instead argued that the authority of thedemocratically elected legislature of South Africa is limited by global rules. This linking of domestic constitutional claims with international trade issues continued when, in a supplementary affidavit to the plaintiff’s amended partic-ulars of claim filed on July 23, 1998, Deeb argued that the USTR’s placing ofSouth Africa on the 301 Watch List “demonstrates that the provisions in theAmended Act which affect intellectual property are seen to be at least poten-tially in conflict with South Africa’s international obligations, and hence, I sub-mit that it cannot be regarded as being in the public interest as it may lead to theimposition of sanctions against this country and will before that in fact may already have lead to an undermining of investor confidence in South Africa.”51Here the pharmaceutical corporation’s legal strategy was able to tie into theefforts of the U.S. government, which entered the debate over South Africa’spolicies and law from an early stage when the U.S. trade representative wrote aletter to South Africa’s United Nations representative in April 1997 queryingSouth Africa’s implementation of TRIPS and raising questions about compul-sory licensing. While the Amendment Bill was still being considered by the leg-islature, the U.S. Embassy in Pretoria formally presented the U.S. government’sobjections to parliament while the U.S. ambassador to South Africa made fre-quent public and private statements against the legalization of parallel imports.
South Africa also became the target of direct bilateral pressure. Within two months of the law’s adoption, the Pharmaceutical Research and Manufacturers ofAmerica (PhRMA) requested the USTR to designate South Africa a priority coun-try under Special 301 of U.S. trade law because “South Africa has become a ‘testcase’ for those who oppose the U.S. government’s long-standing commitment toimprove the terms of protection for all forms of American intellectual property,including pharmaceutical patents.”52 Bristol-Myers Squibb specifically complainedabout South Africa’s decision to permit registration of a generic form of the cancerdrug Paclitaxel (BMS brand name Taxol), an issue that the USTR took up directlyduring a WTO Trade Policy review a year later in Geneva. One month later, on May1, 1998, the USTR put South Africa on the Special 301 Watch List. In June 1998,the White House announced that four items for which South Africa had requestedpreferential tariff treatment under the Generalized System of Preferences programwould be put on hold until adequate progress was achieved in the protection ofintellectual property rights in South Africa. At the end of October, the U.S.
Congress passed an omnibus appropriations bill containing provisions cutting offU.S. aid to the South African government pending a Department of State reportoutlining its efforts to “negotiate the repeal, suspension, or termination of section15(c) of South Africa’s Medicines and Related Substances Control AmendmentAct No. 90 of 1997.” At the end of April 1999, the USTR scheduled an “out-of-cycle” review for South Africa under Special 301, arguing that South Africa’s bar-riers to trade included: parallel imports, compulsory licensing, registration ofgeneric forms of Taxol, and taking a leading role at the World Health Assembly(WHA). According to the USTR: “During the past year, South African representa-tives have led a faction of nations in the World Health Organization (WHO) in call-ing for a reduction in the level of protection provided for pharmaceuticals inTRIPS.”53 Thus, from the perspective of the USTR, the problem was not only theprotection of patent rights in South Africa, but also the position South Africa wastaking in the international debate over TRIPS. From this perspective, the South Africa/United States binational dispute in this period was fairly representative of the broaderinternational struggle over the meaning of TRIPS, especially over the scope of, andexceptions to, internationally recognized intellectual property rights.
At this point, however, the U.S. debate underwent a dramatic shift in response to popular pressure from AIDS-activists and the Congressional BlackCaucus, as a link began to be made between international HIV/AIDS policy andthe question of trade disputes involving compulsory licensing, parallel imports,and other intellectual property issues. In February 1999, Representative JesseJackson Jr. introduced House Resolution 772, the “Hope for Africa Bill.”Section 601 of the Bill proposed cutting off funding to any Department oragency of the U.S. government that sought “through negotiation or otherwise,the revocation or revisions of any sub-Saharan African intellectual property orcompetition law or policy that is designed to promote access to pharmaceuticalsor other medical technologies,” as long as those laws complied with TRIPS.
Two months later, in April 1999, several hundred protestors in downtownWashington, D.C., demonstrated support for the Hope for Africa legislation andfor compulsory licensing for HIV/AIDS and other essential medicines. ACT UP,a prominent U.S. organization with a long history of activism on the issues ofHIV/AIDS, called upon the U.S. Department of Health and Human Services togive the WHO and foreign governments the right to use U.S. government userights in patents obtained with federal funding. HIV/AIDS activists then began a campaign to disrupt Vice President Gore’s presidential election campaign to draw attention to U.S. trade sanctions againstSouth Africa and Thailand. These protests had an immediate effect: whenRepresentative John Mica held hearings in Congress on U.S. trade policy and theglobal AIDS crisis, Joseph Papovich from the USTR testified that the USTR nolonger objected to parallel importing or compulsory licensing of pharmaceuticaldrugs in South Africa, if TRIPS compliant. On September 17, 1999, U.S. TradeRepresentative Charlene Barshefsky announced that South Africa had agreed toimplement the Medicines Act in a manner consistent with its obligations underthe rules of the WTO “enabling us to set aside this issue from our bilateral tradeagenda.” Just over a week before, PhRMA had announced the suspension of thelawsuit brought against implementation of the Medicines Act in South Africa.
Furthermore, officials at the office of the USTR said that they were now consid-ering removing South Africa from the Special 301 Watch List. From the SouthAfrican side, there was a commitment to revisit the Act, although it was predictedthat it would be some time before the government implemented the law. WhenCongress failed to include section 601 in the Hope for Africa Bill, PresidentClinton responded quickly, issuing an executive order on May 10, 2000, statingthat in “administering sections 301-310 of the Trade Act of 1974, the UnitedStates shall not seek, though negotiation or otherwise, the revocation or revisionof any intellectual property law or policy of a beneficiary sub-Saharan Africancountry, as determined by the President, that regulates HIV/AIDS pharmaceuti-cals or medical technologies if the law or policy of the country: (1) promotesaccess to HIV/AIDS pharmaceuticals or medical technologies for affected populations in that country, and (2) provides adequate and effective intellectualproperty protection consistent with the . . . TRIPS Agreement.” While it wouldseem that a partial resolution to the direct conflict between the South African andthe United States government had been found, the international legal regimeestablished under TRIPS remained uncertain.
Social Mobilization, Parallel Imports,Compulsory Licensing, and Public Access The domestic struggle over access to affordable medicines in South Africa did not end with the government’s victory in the PMA case. Despite their sharedvictory in the PMA case, the government and local social movements soonparted ways as the government balked at the demand to provide access to ARVsin the public sector. Instead, the government poured resources into a controver-sial prevention campaign, and the newly elected President Mbeki began to ques-tion the scientific consensus on HIV/AIDS and to doubt the probity of providingaccess to the new ARV treatment regime in the public sector. What became infa-mous as the President’s “denialism” was focused both on questioning the scien-tific basis of HIV/AIDS as well as raising questions about the toxicity of thenew drugs.54 Although there has been a furious debate over the government’sstance—highly critical on the one hand and defensive on the other hand—ofPresident Mbeki and the Minister of Health Tshabalala-Msimang, there can beno doubt that “denialism” has undermined efforts to effectively address the pan-demic in South Africa. In response, civil society, led by a new social movement,the Treatment Action Campaign (TAC)—launched in December 1998, andjoined at key moments by the People Living with AIDS organization as well asthe Trade Union movement, churches, and the Communist Party—began todirectly challenge the government’s handling of the HIV/AIDS pandemic. While the TAC played an important role in the PMA case, by intervening when the case finally went to court in early 2001 and raising the question ofHIV/AIDS, it now initiated a new phase of litigation that led to two further legalvictories. The first case challenged the government to provide mothers and theirnewborn babies access to nevirapine, an anti-retroviral that, when administeredto both mother and child during birth and shortly thereafter, more than halvedthe rate of mother-to-child transmission of HIV. Second, the TAC brought acomplaint before the Competition Board alleging that a number of the majorpharmaceutical corporations had colluded in maintaining the high price of par-ticular medicines. The impact of these two initiatives was to dramatically alterthe debate over access to anti-retroviral treatment and to set the stage for a majorreduction in the price of medicines. The TAC did not, however, limit its activi-ties to litigation, but instead mobilized its members through a variety of cam-paigns and actions, including the illegal importation of “generic” medicines and collaborating with Medicins San Frontiers (MSF) to establish an HIV/AIDSclinic in Khayelitsha, an impoverished community outside Cape Town, whereARV treatment of destitute individuals provided a model for the country. AsSteven Friedman and Shauna Mottiar have argued, the TAC, with its “politics ofthe moral high ground,” has demonstrated that “it remains possible to use therights guaranteed and institutions created by liberal democracy to win advancesfor the poor and weak.”55 In the Mother-to-Child-Transmission (MTCT) case, the Constitutional Court essentially upheld a high court decision requiring the government to providemothers and newborns in public health facilities access to nevirapine.56 Relyingon the constitutional guarantee of a right to the progressive realization of accessto health care services, the Constitutional Court argued that under the circum-stances, in which the cost of the drug and the provision of appropriate testingand counseling to mothers was less burdensome then the failure to providenevirapine, the government had a constitutional duty to expand its programbeyond the eighteen test sites the health authorities had already planned. In thesecond case, the TAC, pursuing its aim to lower drug prices and thus expandaccess to ARV treatment, launched a complaint with the newly constitutedCompetition Commission against two of the major pharmaceutical corporationsactive in South Africa—GlaxoSmithKline (GSK) and Boehringer Ingelheim—accusing them of engaging in excessive pricing of medicines. After theCommission found that the companies had colluded to fix prices, the companiesreached an out-of-court settlement with the government, which included grant-ing at least three generic pharmaceutical companies voluntary licenses on threemajor retrovirals, thus allowing more competition into the market and loweringthe price of the drugs in the South African market.57 Despite these dramaticinterventions and legal victories, the problem of access remains unsolved. Forthe majority of HIV-infected South Africans, even the reduced price of the drugson the private market is unaffordable, and until the government manages to rollout the public sector program, the majority of people in need of treatment wouldcontinue to be denied access.
Despite these legal victories, the HIV/AIDS crisis in South Africa continued to explode—with an estimated 19.6 percent of the population or approximately4.2 million people thought to be HIV-positive as the country approached its firstdecade of freedom in 2004. The debate about what to do continued to rangefrom denial to dreams of local vaccine breakthroughs, and on to public acts oflaw breaking as activists of the Treatment Action Campaign announced thearrival of members bearing generic pharmaceuticals from Thailand in defianceof the patent rights guaranteed under South African law. At market prices ofbetween US$5,400 and $10,000 per patient per year in 2001, it was estimated thatto provide anti-retrovirals alone would cost between US$24 and 42 billion—one hundred times the national public health budget. Even with a 90 percent discount (now offered by some of the pharmaceutical corporations), the cost oftreating all 4.2 million would equal approximately ten times the national publichealth drug budget. However, with Bangladeshi and Indian firms offering a“generic” version of these drugs at 3 percent the South African costs, it startedto become more costly for the government not to provide treatment—given theexpected costs of hospitalization and the impact on the economy of work andskill losses.
To access these drugs under these pricing conditions, however, South Africa would have had to issue compulsory licenses allowing the importation of these“generics” against the wishes of the local patent holders. It is precisely this capac-ity that was provided for in section 15C of the 1997 law and which remainedlocked in legal conflict. Act 90 of 1997 provided for a range of mechanisms aimedat implementing South Africa’s new Drug Policy and improving access to essen-tial medicines. As mentioned already, the Act empowered the Minister of Healthto allow parallel imports—on the theory of patent exhaustion—and compulsorylicensing. However, parallel imports alone would not have a significant impact onthe public sector, it is estimated that it could reduce private sector prices byapproximately 20 percent. Significantly, the Act also provides for a range of othermeasures including: generic substitution (allowing pharmacists to dispense ageneric when a doctor prescribes a brand-name medicine); the prevention of per-verse incentives (by requiring a single-exit price and professional fees rather thanmargins); marketing control (restricting bonusing, sampling, etc.); licensing dis-pensing doctors; and it establishes a pricing committee.
Compulsory licensing is, in fact, already permitted in South Africa under sec- tions 4 and 56 of the Patents Act 57 of 1978, yet the specific attempt in Act 90 of1997 to empower the Health Minister to act on this, elicited major internationalreaction—as noted above. Yet, it seems that it is only compulsory licensing—which has the potential of creating savings of anywhere between 10 and 97percent, depending on the differential pricing of the relevant drugs—that holdshope for South Africa’s HIV-positive population of approximately 4.2 million.
Although it is true that approximately 97 percent of the drugs on the essentialdrug list are in fact off-patent, the anti-retrovirals essential to combat HIV andthe most powerful drugs required to treat the opportunistic infections sufferedby HIV/AIDS patients—such as Fluconazole, which is effective againstCryptococcus Meningitis and Oesophageal candidiasis (Candidia)—were, at thetime, expensive patented drugs. Without treatment, Cryptococcus Meningitisoften kills within a month. Take Fluconazole as an example. Marketed by Pfizer in South Africa—which had patent protection until June 6, 2002—the retail price was $18 per 200 mgcapsule ($8.14 wholesale and $4.10 to the public sector). By comparison,generic companies in Bangladesh were producing the same capsules for justover 14 cents per dose—3 percent of the price in South Africa. What would it take for South Africa to provide widespread access to such drugs? While allow-ing parallel importation of brand-name drugs from neighboring countries—where they are on the market for as much as a third less—might have providedsome relief, it seemed that only compulsory licensing, which would generateeffective “generic” competition, could bring the costs within reach of the coun-try. While the Clinton Executive Order of May 2000 seemed to provide a breath-ing space for sub-Saharan nations, the requirement that any actions must beconsistent with the particular country’s TRIPS commitments in fact begged thequestion. The Executive Order clearly relieved South Africa from the directpressure of immediate U.S. demands for the creation of a TRIPS-plus intellec-tual property regime; however, it was still necessary to define what exactlycould be achieved within the meaning of TRIPS.
While parallel importation was made possible through the adoption of the doctrine of exhaustion, and is deliberately set aside under article 6 of TRIPS forindividual country determination, the validity and scope of a range of otheroptions open to South Africa and other developing countries remained highlycontested. In the case of compulsory licensing, for example, the pharmaceuticalmanufacturers in South Africa argued that it is directly in violation of theirpatent rights and South Africa’s international commitments, particularly TRIPS.
The International Federation of Pharmaceutical Manufacturers Associationssuggested that compulsory licensing “is normally limited in application to extra-ordinary circumstances”58 and pointed to the Canadian repeal of their compul-sory licensing law in 1992 as proof of the problem with this strategy. Bycontrast, Carlos Correa of the South Centre—an intergovernmental organizationof developing countries—argued that TRIPS “specifically allows MemberStates to grant compulsory licenses on grounds to be determined by each mem-ber country (Article 31).”59 Two of the nonexclusive grounds covered in TRIPSare, according to Correa, cases of declared national emergency and when“required for reasons of public health, such as to ensure the availability to thepopulation of essential drugs, or when required in the public interest, includingsecurity reasons.”60 Adopting a strategy of compulsory licensing under TRIPSdoes, however, require adherence to a number of conditions, including: that insome cases a license be voluntarily requested before being granted on compul-sory terms, non-exclusivity, and an adequate remuneration to the patent holder.61 Following the dramatic collapse of the PMA case, the drug companies in South Africa began to offer to provide some drugs for free. In the case ofFluconazole, Pfizer offered to provide the drug free of charge for patients inSouth African government hospitals and clinics who could not afford it. At thesame time, five of the other major producers of HIV/AIDS drugs—GlaxoWellcome, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, and Merck andCo.—offered to negotiate reduced prices with the South African government, asthey had begun doing with a number of other African states. In the case of Boehringer Ingelheim, the South African government accepted a five-year dona-tion of nevirapine to be used in the treatment of pregnant HIV-positive womento reduce the mother-to-child-transmission rate. Yet, despite these dramaticinterventions and legal victories, the problem of access remained unsolved. Forthe majority of HIV-infected South Africans and many others in developingcountries around the world, even reducing the price of the drugs on the privatemarket is not enough, as the drugs will remain unaffordable. Until governmentsmanage to sustainably provide these medicines through the public sector, thepoor and marginalized, who make up most HIV-positive people in the world,62will continue to be denied access.
The Doha Declaration on TRIPS and Public Health In dire need of success after the Seattle debacle, the WTO was able to declare the launching of a new round of trade negotiations at the end of its DohaMinisterial Conference on November 14, 2001. An essential ingredient was theissuing of a separate declaration on TRIPS and public health. Despite concertedopposition from multinational pharmaceutical corporations and a group ofdeveloped countries led by the United States, Switzerland, and Japan, the 140trade ministers gathered in Doha, Qatar, agreed that the TRIPS agreement “doesnot and should not prevent Members from taking measures to protect publichealth. . . [and] that the Agreement can and should be interpreted and imple-mented in a manner supportive of WTO Members’ rights to protect public healthand, in particular, to promote access to medicines for all.”63 This was a surpris-ing victory for the global coalition of non-governmental organizations (NGO)and developing countries that had argued in the TRIPS Council in Geneva thatthe TRIPS agreement was limiting access to essential medicines in developingcountries. This was achieved not only by the growing awareness of theHIV/AIDS pandemic and the dire impact of unequal access to the new ARVmedicines that had become available after the signing of the TRIPS Agreementin 1994, but also because of the blatant hypocrisy of the United States andCanada after they thought they would be in desperate need of Cipro, anadvanced antibiotic that was needed for the treatment of persons who mighthave been exposed to the deadly Anthrax toxin. Despite their opposition to a broad public health exception, it was the United States and Canada’s own threats to use compulsory licensing to overrideBayers’ Cipro patent—in response to the mailed Anthrax attacks afterSeptember 11, 2001—that completely undercut their claims that stronger patentprotection was the most effective means of securing access to required medi-cines. The threat to use compulsory licensing to increase production and reducethe price of Cipro was made in response to the sudden need by the U.S. govern-ment to procure what they feared might be vast stockpiles of Cipro to safeguard against a bioterrorism attack. The decision to stockpile Cipro came in responseto a series of attacks around the United States in which Anthrax-laden envelopeswere mailed to various individuals, including politicians. Coming shortly afterthe attacks on the World Trade Center, the Pentagon, and the hijacking of flightson September11, 2001, these attacks raised enormous concern about bioterror-ism. As a result of the threat to issue compulsory licenses, Bayer, the patentowner of Cipro, immediately agreed to increase production and to supply thedrug at a much lower cost. With their prior arguments about the sanctity ofpatents and the dangers of compulsory licensing severely compromised andwith no other effective means of addressing the ongoing HIV/AIDS pandemic,the U.S. trade representative, Robert Zoellick, seemed to decide that acceptingthe demands of developing countries became the easiest way to save the talks.
Addressing what had been an intense debate within the TRIPS council, the dec-laration specifically clarified the right of members: to grant compulsorylicenses, to determine what constitutes a national emergency or other circum-stance of extreme urgency, and that each member is free to establish its ownregime for the exhaustion of intellectual property rights. It also encouragesdeveloped countries to promote technology transfer to the least developed coun-tries and extends the initial transition period for pharmaceutical products inthose countries until January 1, 2016. This understanding of the TRIPS agreement and its future implementation amounted to a major shift in the rhetoric about the protection of intellectualproperty rights, embracing as it did most of the positions of the developingworld—with much of the language for the declaration coming directly from theproposal put forward by Zimbabwe on behalf of the Africa Group and otherdeveloping countries. Thus, at first glance, it seemed as if the developing worldhad gained a major success. Not only is the broad interpretation extended to allaspects of public health—not just pharmaceuticals and not just the three namedepidemics—it also emphasizes the need to interpret the WTO agreements inmore holistic ways. In essence, it accepts that an interpretation reducing barri-ers to free trade is not automatically the sole or correct understanding of theagreements. At the same time, the Doha Declaration, while relying on claims offlexibilities within the TRIPS agreement, postponed to future negotiations themost difficult and important issue—how to ensure access to medicines in coun-tries that do not have manufacturing capacity. In this respect, the DohaDeclaration, heralded as a major success by the global NGO groups that foughtso hard for it, did not go very far toward ensuring access to urgently neededHIV/AIDS related medications. Given the realities of pharmaceutical production and distribution, even the recognition of a country’s right to issue compulsory licenses to produce medi-cines needed to address a public health crisis within its own borders was a prob-lematic solution when considered in terms of the economies of scale needed to bring the cost of production within the overall budget capacities of these coun-tries. Despite acknowledging that many countries have “insufficient or no man-ufacturing capacities in the pharmaceutical sector” and thus cannot makeeffective use of compulsory licensing, the declaration failed to accept the devel-oping countries’ interpretation that they have the right to grant a compulsorylicense to a producer in another country having manufacturing capacity to gainaccess to medicines. Instead, the declaration instructed the TRIPS Council tofind a solution to this issue and to report to the WTO General Council by theend of 2002. Without the capacity to produce under compulsory license orimport generic equivalents of the necessary medications, the problem of accessfor the millions infected or suffering from life-threatening diseases in develop-ing countries remained unresolved. It took the TRIPS Council a further twenty-one months, to late August 2003, to reach agreement on the problem of accessto medicines for countries that do not have manufacturing capacity. Heralded at first as the solution to the problem of lack of capacity, the August 30, pre-Cancun agreement has since been criticized for placing so many prereq-uisites on its implementation so as to make it unworkable. These limitationsinclude the requirement of proof by a country that it does not have (1) productioncapacity, (2) access to affordable medicines, and (3) has an existing health emer-gency. Even as the Canadian government moved to amend Canadian law to makethe export of medicines made under compulsory license possible, the internationalbrand-name pharmaceutical industry began to raise questions about whetherCanada is not precluded from supplying these medicines under the NAFTAAgreement. Furthermore, the Canadian government limited its legislative amend-ments to drugs designed to address only HIV/AIDS, malaria, and tuberculosis(TB), a restriction rejected by developing countries and the pre-Cancun agree-ment. Despite the simple requirement that Member states merely notify the TRIPSCouncil of their intention to use the paragraph 6 mechanism, it would take untilJuly 2007 before any country would take advantage of this “flexibility.” In thiscase, Rwanda announced that it was issuing a compulsory license to import a two-year supply of ARVs, and shortly thereafter, Canada announced that it would pro-vide the corresponding compulsory license that would allow the Canadianproducer to supply the Rwandan order. Despite this example, other countries andNGOs remained skeptical that the degree of coordination required, including lim-ited orders and specific time periods, would encourage the investments needed bygeneric producers to establish the production facilities that would guarantee thelevels of competition that leads to a genuine and sustained fall in prices necessaryto guarantee access to essential medicines around the world.
While it may seem a logical position to argue that any country in need of access to medicines to address a public health crisis need only declare a state ofemergency or a public health emergency to use the so-called TRIPS flexibilities,such as compulsory licensing, in fact this option is not as simple as it seems.
Declaring a public health emergency is both a statement of government failure aswell as a sure way to undermine the confidence of foreign investors and tourists.
Given the dependence of many developing countries on foreign tourism andinvestment, it should not be a surprise that the governments of these countries areextremely reluctant to declare such emergencies. Aside from these concerns,there is the fact that local leaders and their governments, particularly in countriessuch as Brazil, India, Thailand, and South Africa, have a degree of nationalistpride that tends to see them asserting their own strategies rather than acknowl-edging local failures. Furthermore, the attempt by developed countries to limitthe Doha Declaration to the specifically named diseases, HIV/AIDS, malaria,and TB, was in direct opposition to the claims of developing countries that allessential medicines necessary to promote public health be exempted from the rigorsof the TRIPS regime. Finally, even if countries were to declare health emergenciesand pay the cost of the negative publicity that would follow, it is unclear that manyof these states would be able to effectively use the available mechanisms—compulsory licensing and parallel importation. It is the limitations on the supplyside, particularly since India became TRIPS complaint in January 2005, that posethe greatest uncertainties for public officials in countries that do not have thelocal capacity to produce these medicines, at least on the scale that is necessaryto make them available at affordable prices. And even when they do have thiscapacity, as in the case of Thailand, the attempt to use it has led to direct conflictwith the multinational pharmaceutical corporations. Abbott Laboratories threat-ened in 2007 to pull all its products from the Thai market after the Thai govern-ment issued a compulsory license on an Abbot drug.64 Once again, it seems that the question of access to essential medicines is being displaced by an assertion of prior legal commitments—the idea of pactasunt servanda,65 in which concerns over the rights of patent holders and an inter-pretation of the TRIPS agreement as a contractual arrangement, place notions ofunrestricted trade before the health needs of millions of people around theworld. While all participants in the debate deny any intention to restrict access,or that there is even such an effect,66 it seems hard to deny that the failure toresolve this issue—since it was first raised by the international pharmaceuticalindustry in its 1997 case against South Africa, as that country attempted toimplement an essential drugs program—has, in fact, frustrated attempts tobroaden access. Even if it is accepted that the TRIPS agreement initially failedto accommodate the complexities of a global health emergency such asHIV/AIDS, it is hardly unreasonable to suggest that the principle of changedcircumstances—or rebus sic stantibus67—brought about by both new under-standings of the magnitude of the pandemic as well as the emergence of effec-tive medicines to address it, should have been applied to interpretations ofTRIPS to facilitate all attempts to address this exploding crisis. At the very least,such an approach would justify the assertion of an Article 30 general exception under the TRIPS agreement. Instead, there has been a constant emphasis uponthe rather unique protection of private rights contained in TRIPS and a denial ofthe legal effect of the so-called soft-law exceptions and principles of interpreta-tion, which are also part of international trade law, including TRIPS.
Drug Prices, Philanthropy, and the Problem of Sustainability While it is clearly true that drug prices are not the only issue limiting access to essential medicines in developing countries, the cost of medicines remains acentral concern, because unlike the broader structural problems of upgrading thehealth care system or monitoring patients, there are just no substitutes or alter-natives to the provision of these particular drugs. To this extent, the cost of themedicines is in fact the “inelastic” part of the essential medicines equation. Yeteven as innovative programs have been designed to facilitate access to healthcare, monitoring, and so forth,68 the debate over drug costs has focused on col-lective purchasing strategies, philanthropic initiatives, and international assis-tance or aid rather than on the creation of a competitive market, which would bethe most effective way to reduce prices and increase supply. Nevertheless, ARVdrug prices have fallen dramatically from about $10,000 per patient per year inthe late 1990s to about $99 today, in some cases.69 The actual cost of providing“free” drugs, even through many of the philanthropic schemes, remains slightlyabove the actual cost of large-scale generic production and distribution becauseof the insistence by developed country governments that these medicines bepurchased from the brand-name firms or their licensed producers—as it the casewith the U.S. President’s Emergency Plan for Aids Relief (PEPFAR)—orspecifically marked and packaged to avoid their illegal re-importation and dis-tribution in developed country markets. Even as prices have dropped and aidincreased, the question has arisen as to whether these developments will be ableto assure a stable supply of these medicines. Given the fact that there is noknown cure, the stable and affordable supply of these medications are essentialto the productive lives of millions of HIV-positive individuals around the worldand particularly in developing countries. To evaluate the stability of any policy or program to provide access to afford- able essential medicines, it is important to briefly review the political pressuresand sources of supply that have brought down the cost of these medicines overthe last few years. First, it was the offer by Indian drug producer Cipla in March2001 to provide the first generation ARV drugs for $350 per patient per year todeveloping countries, a fraction of the going price in the developed country mar-kets, that brought about the initial fall in prices.70 Although Brazil had alreadymanaged to reduce the price from $10,000 per patient to around $2,800 perpatient within its own public health system, this was based on the government-controlled industry’s capacity to reverse engineer and manufacture the relevant drugs. Second, it was the response of the multinational drug companies to theaccusations of activists and the bad publicity they received after they sued theSouth African Government and named President Nelson Mandela as the firstdefendant, that led to offers by these companies to supply drugs to some devel-oping countries at vastly reduced costs and in some cases at no cost, for certainperiods of time and for specified classes of poor patients. Third, the establish-ment of the Global Fund and later President George W. Bush’s PEPFAR initia-tive provided a source of funding for anti-AIDS programs, including theprovision of essential medicines in the public sector. Fourth, the entry of theGates and Clinton Foundations as both funders and as a source of political coor-dination of efforts aimed at the procurement of cheaper drugs bolstered thelongstanding efforts of non-government organizations such as Doctors WithoutBorders, James Love’s Consumer Project on Technology, the CanadianHIV/AIDS Legal Network, and the AIDS Law Project in South Africa as wellas various AIDS-specific activist organizations, such as ACT UP in the UnitedStates and the South African-based Treatment Action Campaign. Finally, theestablishment in 2006 of UNITAID, initiated by the governments of Brazil,France, and Norway promised a long-term source of funding through a type ofTobin tax71 on international airline ticket sales and an international organizationcommitted to pooling demand and using the resulting bargaining power toobtain medicines at reduced cost in the international market.
While these different initiatives and strategies have very different protagonists and modes of operation, the underlying premise of all these strategies is the con-tinued existence of an adequate supply of the required medicines at affordableprices. Already there have been a number of incidents in which the supply of ARVshas been interrupted, with obvious consequences for individual patients and possi-ble drug resistance if patients are unable to maintain their treatment programs. Inthe case of the ARV ritonavir, for example, there were five occasions in 2004 whendrug companies in South Africa were unable to supply the drug,72 in either pedi-atric dozes or adult capsules, forcing patients to switch their medications and lead-ing the South African government to briefly halt the rollout of their public sectorprogram for children. These incidents and concern over the cost of second-linedrugs as well as the WHO’s new treatment guidelines, which suggest the use ofmore expensive drugs,73 raise questions about the stability and sustainability of thesupply chain of affordable drugs. To understand the magnitude of this problem, itis important to note two facts: first, that under normal conditions, the cost of apatented drug drops by only 20 percent when the first generic enters the market atthe end of the patent term, and second, it is only when there are three or moregeneric companies competing to supply a particular drug that the cost falls to any-where between 70 and 90 percent below the original price of the patented drug.74 Until 2005, this was not a dramatic problem because Indian drug producers were able to produce “generic” versions of these medicines as long as they were able to come up with a process of production that had not been previouslypatented. As a result, Indian pharmaceutical companies have in recent yearsbeen producing approximately “one-fifth of the world’s generic drugs.”75 Theimplementation of the TRIPS agreement in India since January 2005, whichrequired the reintroduction of product patents into Indian law, now precludes thepossibility that these companies will be able to produce “generic” versions ofthe next generation of ARVs, and henceforth, the only way these companies willbe able to enter the market to provide “generic” forms of any new drugs will beas licensed producers, whether under voluntary or compulsory licenses.76 InSouth Africa, the brand-name companies have increasingly licensed local man-ufacturers to produce their products for the local and regional market. Mostprominent of these companies is Aspen Pharmacare, whose main aim is toacquire patent-expired medicines from multinational drug firms and which nowcontrols 35 percent of South Africa’s generic drug market.77 While the turn tolocal licensing may have been made in the face of growing international pres-sure and after settling the case against them before South Africa’s CompetitionCommission, a number of the brand-name companies have now licensed Aspento locally manufacture their products. Aspen has in turn succeeded in having itsnewly constructed oral solid dosage (OSD) plant in the Eastern Cape region ofSouth Africa approved by both the “local regulator, the Medicines ControlCouncil, [and] . . . the American Food & Drug Administration and the UK’sMedical Health & Regulatory Authority.”78 This placed the company in a posi-tion not only to win the South African State Tender in 2004, producing nearlyone-half billion dollars worth of ARV drugs over three years, but also to poten-tially win large international aid contracts from PEPFAR and the Global Fund.79 While the Brazilian and Thai governments have stood up to pressures from the United States and multi-national drug companies by either issuing compul-sory licenses for the local production of needed medicines or negotiating locallicenses and affordable prices under the threat of compulsory licensing, thisoption requires either a state-owned pharmaceutical producer, as in the case ofBrazil, or the political courage to take on the industry, as Thailand has recentlydone. In both of these cases, the target has been domestic supply coupled withlocal production capacity, which is well protected by the Doha Declaration. Theproblem for most developing countries is that they lack either domestic produc-tion capacity altogether, or their internal markets are too small to sustain thelevel of production that is needed to gain the cost-cutting benefits of large-scaleproduction. While the paragraph 6 negotiations and subsequent amendment tothe TRIPS agreement were supposed to address this difficulty, the failure ofcountries to make wide use of these provisions indicates that there is substanceto the claim of critics that the “safeguards” insisted upon by the developed coun-tries and multinational drug companies have, in fact, proved too burdensomeand undermined the effectiveness of this solution. Despite the falling prices, company giveaways, and philanthropic efforts, Oxfam International has recentlynoted, “the inability of the Paragraph 6 solution to deliver medicines is a seri-ous threat to the legitimacy of the WTO.”80 Furthermore, despite the designationof health as a priority in the Millennium Development Goals adopted by worldleaders in 2000, and the Doha Declaration on Public Health adopted inNovember 2001, more than 20 million more people have been infected withHIV since that time, and the cost of medicine still “represents the greatest shareof health-care expenditures for people in poor countries.”81 Global Governance of Access to Medicines The struggle over access to essential medicines makes it clear that the avail- ability of life saving pharmaceuticals is not the simple function of any nation’sdisease burden and domestic health policies. Instead, the question of access, andparticularly sustainable access, is intimately bound up with the question of gov-ernance, in the sense that any decision to facilitate access has been embedded ina broader set of issues relating to trade, development, intellectual property, andinternational assistance programs, including the philanthropic activities ofmajor foundations and pharmaceutical corporations. To understand the effectsof these processes of governance, it is important to unpack the relationshipbetween domestic or national decision making and the international or globalregime as well as the interactions of different global governance regimes thatimpact the capacity to make local health-related choices. In the case of phar-maceuticals, there is a range of different governance issues that are the subjectmatter of different governance regimes, including the discovery, testing, manu-facture, distribution, and monitoring of the effects of each new compound aswell as issues such as intellectual property rights, which are beyond the purelyscientific or medical dimensions of medical technology.82 Even at a global level,this analysis requires both the recognition of the different regimes involved aswell as an understanding of how the very nature of each particular regimeeffects the governance of the substantive issues at stake. While it is well recognized that international relations and governance may be viewed through the perspective of a number of different regimes consisting ofdifferent participants, epistemic communities, subject matter, and rules, the ques-tion of how to ensure access to essential medicines demonstrates the importanceof exploring both the nature of each of these particular regimes as well as theirinteraction. Since the Second World War, it may have been assumed that publichealth issues, particularly those with transnational effects, would be coordinatedthrough World Health Organization as the relevant body within the UnitedNations system. This role is reflected in the WHO constitution, which empow-ered the organization’s governing body, the World Health Assembly, to adoptconventions as well as other international legal instruments, including binding regulations.83 In practice, however, WHO has until very recently relied more onthe adoption of standards, principles, and models supplemented by the body’sannual reports and occasional declarations such as the Alma-Ata Declaration,which called upon countries and international organizations to adopt a system ofprimary health care. When it came to the regulation of pharmaceuticals, theessential medicines program, legally premised on the idea of advancing a modellist of drugs for adoption by national governments, fit precisely into the mode ofsetting standards rather than rules. Any binding legal rules controlling the avail-ability of medicines remained rooted in two independent legal processes withinnational jurisdictions, one regulatory and the other based on the laws of the mar-ket, including the relevant intellectual property rules in each country.
The WHO was formally establish on April 7, 1948, after twenty-six states had ratified the organization’s constitution, which was described as the “MagnaCarta” of health.84 With a membership of 193 states—that originally signed ontothe organization’s constitution or have subsequently been admitted by its gov-erning body, the World Health Assembly—the WHO is a large institutionalbureaucracy with its headquarters in Geneva, Switzerland, and offices aroundthe globe. The professional staff and leadership of the institution are unsurpris-ingly dominated by the medical profession. Like most other multilateral institu-tions, the WHO is comprised of member states. While global health matters areformally within its jurisdiction, most of the work of the WHO is focused onmonitoring and providing assistance at the request of its member states. Theprinciple of universality led the WHO to open its membership to all countries,not just member states of the United Nations. At the same time, the sense of theorganization as reflecting the responsibilities of doctors would remain a centralfeature of the internal culture of the institution. By comparison, the WTO is a very new institution. Established as a product of the Uruguay Round of the GATT, which was only completed in 1994, theprocess of negotiations that produced this agreement were premised on the long-standing procedures of the GATT, in which trade officials reached consensus onparticular tariff reductions suitable to each member state, who could choose toparticipate or not in the particular trade facilitating process. The essence of thisprocess was bargaining between trade specialists. It was this same epistemiccommunity that, in the context of TRIPS and the HIV/AIDS pandemic, contin-ued to seek trade-offs, whether it was allowing flexibility but trying to limit theseto particular epidemics—such as HIV/AIDS, TB, and malaria in the DohaDeclaration—or in acknowledging the right of a country to issue a compulsorylicense for medicines, but requiring that at least 50 percent of the production beconsumed within that particular country. The norms of this particular epistemiccommunity—including many of the trade lawyers and economists who served asadvisors—facilitated their cooperation with the officials and lawyers, who werepromoting intellectual property rights. But this led to frustration when they engaged with the non-governmental activists and human rights-oriented commu-nity, who insisted that health needs could not be simply bargained away or thatpharmaceuticals should be viewed as public goods, and access to innovations inthis area should be the primary goal of the intellectual property system, not justincreased protection of the property rights of patent holders. These professionaland political differences came to the fore in a series of meetings between mem-bers of the TRIPS Council, participants from the World Health Organization, andvarious NGOs and representatives from the pharmaceutical industry—both thebrand-name and generic producers. Even though it was broadly understood thatthe TRIPS agreement introduced a new set of minimum standards for the pro-tection of intellectual property rights, the emergence of the HIV/AIDS pandemicand the resulting demands for greater access to the life-saving medicines thatcame on line after 1996 meant that there was wide disagreement as to the mean-ing of the embedded exceptions to those rights. It was in this context that the WHO began questioning the relationship between the new international trade regime and its own mandate to promoteworld health. In January 1998, just over a month after the adoption of the newSouth African law allowing parallel importation, the Executive Board of theWorld Health Assembly (WHA) recommended the adoption of the “RevisedDrug Strategy,” calling upon member states to “ensure that public health inter-ests are paramount in pharmaceutical and health policies,” as well as “to exploreand review their options under relevant international trade agreements, to safe-guard access to essential drugs.”85 In May 1998, when the WHA began dis-cussing the recommendation at its meeting in Geneva, the proposal came underheated attack from the developed countries including the United States, EU, andJapan. Supporting the proposals and leading the negotiations for the Africancountries was Dr. Olive Shisana from the South African Ministry of Health.
Although action on the resolution was initially deferred, a bitter conflict eruptedover the strategy. An Ad Hoc Working Group of 59 countries met in October1998 with South Africa and the United States representing the polar oppositepositions. South Africa advocated for a strong public health statement, while theUnited States represented the pharmaceutical industry’s point of view.86 InJanuary 1999, the WHA Executive Board met and approved the Revised DrugStrategy in the course of which South African health official Dr. Desmond Johnsmade comments that emphasized the strategy’s openness to the parallel impor-tation and compulsory licensing of pharmaceuticals, an interpretation in conflictwith the understanding of U.S. officials and PhRMA, which had a diametricallyopposite interpretation of these developments.87 Since then, the United Stateshas continued to use bilateral agreements to pursue its agenda of promotingTRIPS-plus standards, as well as applying pressure on WHO staff to stop“engaging in or publishing research or statements that critique the impact of UStrade policy on Public Health.”88 AND THE IMPACT OF A GLOBAL SOCIAL MOVEMENT After twenty years, the HIV/AIDS pandemic has finally been recognized as a global health crisis, yet the debates over access to public goods, which areessential to defeating this scourge, continue to be shaped less by principles ofpublic health than by concerns over unrestricted trade and intellectual propertyrights. Within the legal field, the claims of the international patent-based phar-maceutical corporations are framed as rights to property, while the claims ofNGOs and developing country governments seeking access to affordable medi-cines are characterized as legal exceptions to free trade or as the soft law con-tained in general preambular statements. These formal legal distinctions, basedupon the interpretation of international agreements created in a context of asym-metrical power, are now relied upon to delay and avoid recognizing the urgentneeds of those whose very lives and futures are at stake. But the emergence ofa new social movement, both domestically and transnationally, based on a newsolidarity that placed public needs over corporate claims of property rights,began in the late 1990s to shift the balance of power. Driven by this newsolidarity—which brought together a unique yet loose alliance of health, humanrights, and development activists together with some governments and parts ofthe pharmaceutical industry, particularly generic producers—the internationalintellectual property and trade regime that had been homogenized and global-ized under TRIPS started to be reopened. First, there was a new assertion of a human rights perspective, in which the health impact of any particular legal option or interpretation was claimed to bean equally legitimate consideration in evaluating the validity of any particularintellectual property or trade rule. Second, there was growing recognition thatboth health and human rights considerations are an essential corrective to thepresent distinction between so-called hard law obligations and soft law princi-ples or commitments. Third, it was hoped that the acceptance of theseapproaches to the interpretation of the TRIPS agreement may facilitate accessto medicines by emboldening private investors to accept compulsory licenses orother exemptions as sufficient to secure their needed investments in generic pro-duction. Finally, the goal was that such an approach would also provide devel-oping countries with a means to justify decisions to privilege policies securingaccess to medicines over concerns about their international trade commitmentsor threats from patent holders. Instead of relying on thin strands of legal flexi-bility, NGOs, international organizations, countries, and governments attempt-ing to address the global HIV/AIDS pandemic were encouraged to look to thebuilding of this new, multifaceted, and complex solidarity to assert a humanrights–based interpretation of the international trade and intellectual propertyregime—one which places public health ahead of property claims.
In practice, I would argue that this new global solidarity achieved more at the local level than globally, although it has managed in some ways to destabilize orat least reopen the debate over the TRIPS regime. Although the conflict over thesupply of essential medicines in South Africa is at one level an integral part ofSouth Africa’s quest to deal with the legacy of apartheid and to fulfill the promiseof the new Constitution—including specific constitutional commitments to anexpanding right to health—this conflict was also driven by the international inter-vention that focused on the scope and definition of intellectual property rights.
Suing Nelson Mandela to prevent his government from implementing a WHO-inspired essential medicines program was symbolically the kiss of death for thepharmaceutical corporations, yet it was only with the local intervention of theTreatment Action Campaign that this case was linked directly to the HIV/AIDSpandemic, and the industry was forced to withdraw its claim. The role of privateinterests on the one side and social movements on the other is a key aspect of thisengagement at all levels of scale—local, international, and global. While the United States, whose domestic trade law and agenda were shaped by the same private interests and Al Gore, personally, through his co-chairmanship ofthe U.S./South Africa Bilateral Commission, were prepared to exert extremepressure on South Africa—including the denial of trade preferences, intergov-ernmental aid, and even the threat of trade sanctions—to pursue the USTR’sinterpretation of TRIPS, particularly its denial of the legality of parallel impor-tation and compulsory licensing; the appearance of ACT UP activists at Gorecampaign rallies introduced a further political dimension to the debate. VicePresident Gore could not be seen to condemn HIV/AIDS victims in Africa todeath in the name of international intellectual property rights. Thus, although itwas the emergence of the idea of linkage—in international diplomacy and nego-tiations over the WTO and TRIPS—that allowed the advocates of stronger intel-lectual property rights to link the recognition of a minimum standard ofprotection of IP rights to the benefits of joining the WTO, it would be this sameprocess of linkage that changed the balance of political forces and reopened thestruggle over the scope of the exceptions included within TRIPS.

Source: http://www.ata.boun.edu.tr/scanneddocuments/Course_Material/ATA_582/Politics%20Society-2008-Klug-207-45.pdf