Source: http://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780199676743.001.0001/acprof-9780199676743-chapter-1
Timestamp: 2019-04-19 02:22:12+00:00

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Chapter 3 Brazil and the Case of Patents and Access to Medicines: A Medical Condition?
Chapter 6 A Golden Straitjacket?
This chapter first sets out the book's purpose, which is to examine the debates concerning aspects of intellectual property law that bear on access to medicine; that is, the measures that regulate the acquisition, recognition, and use of patent rights on pharmaceuticals and trade secrets in data concerning them, along with the conditions under which these rights give way to the interest in public access to cheaper generic drugs. The book presents the results of a comparative study on intellectual property and access to medicines in eleven Latin American countries: five from South America (Argentina, Brazil, Chile, Colombia, and Ecuador), and six from Central American (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua). The chapter then discusses the discourse of global administrative law; theories of political contestation that underlie the analysis; and the concepts of intellectual property law relevant to the medicines debate and to a history of the region. An overview of the subsequent chapters is also presented.
In terms of the global administrative law (GAL) framework articulated by Benedict Kingsbury, Nico Krisch, and Richard Stewart (2005), intellectual (p.2) property is, like climate control, monetary policy, and national security, an area where the activity in one country has significant spillover effects in others. Thus, as with these other areas, it too has become subject to a highly complex transnational regulatory framework. As the shift from WIPO to the WTO suggests, the creative industries, along with the governments in the global North where this sector is largely based, have mounted increasing pressure for regulatory convergence on high standards (Sell 2003) and have used a variety of national, international, and private forums in their efforts to ratchet up protection. The regulatory regime now emanates from diverse sources, ranging from the hard law adopted by WIPO and the WTO, to soft law and enforcement initiatives undertaken by such public institutions as the World Health Organization (WHO), the World Customs Organization (WCO), and Interpol (Robinson 1999; Sandhu 1999). Further, it includes reactive counter-norms articulated for the benefit of the South by pro-development organizations such as the United Nations Conference on Trade and Development (UNCTAD) and WHO (Dinwoodie and Dreyfuss 2012); measures promulgated by private bodies, such as ICANN, which administers the internet, and standard-setting organizations, which determine the technical specifications for new products; as well as distributed administration carried out by national governments and dispute resolution panels, such as the DSU’s Dispute Settlement Body (DSB) and the arbitral panels created by free trade agreements (FTAs), bilateral investment treaties (BITs), and the like (Grosse Ruse-Khan 2011). In the final analysis, the intellectual property system represents a prime example of a “global administrative space,” in which “states, individuals, firms, NGOs [(nongovernmental organizations)], and other groups or representatives of domestic and global social and economic interests who are affected by, or otherwise have a stake in, global regulatory governance, interact in complex ways” (Kingsbury et al. 2005: 26).
But notwithstanding this multilayered regulatory environment, intellectual property law remains quintessentially territorial law. For many reasons this is not surprising: intellectual property is intimately tied to culturally constructed notions of authorship and inventorship. The law must take into account national views on the value of innovation, local intellectual capabilities and propensities, as well as the population’s capacity to pay for, and the government’s commitment to supply, knowledge products. The TRIPS Agreement is, therefore, a minimum standards regime. It establishes a global network of rights through requirements for national treatment and most favoured nation privileges. However, it is not a fully harmonized system. Nations retain considerable sovereign authority to tailor the law to their own interests. TRIPS, for example, allows governments to define terms (such as “inventive step”) in a fashion that reflects local interests, to use flexibilities (such as compulsory licenses and rules permitting importation from low-price providers) to meet local demand, and to make exceptions (such as defenses based on national health needs and ordre public imperatives) to respond to local circumstances. In short, the global framework leaves considerable space for national variation.
(p.3) This book focuses on how the variation in legal norms and practices occurs; how the complex interactions among actors in this regulatory field—national governments, international institutions, public and private regulators, courts, transnational corporations (TNCs), national producers, corporate lawyers, and NGO activists—shape (and are shaped by) local and international law. Specifically, we examine the debates concerning those aspects of intellectual property law that bear on access to medicine; that is, the measures that regulate the acquisition, recognition, and use of patent rights on pharmaceuticals and trade secrets in data concerning them, along with the conditions under which these rights give way to the interest in public access to cheaper generic drugs.
One of a series of studies commissioned as part of a larger project on global administrative law, the volume has three goals. First, we aim to document cross-country variation in this critical area, where the need to offer monetary incentives to research aimed at curing disease is as uncontestable as the public benefit in providing wide access to the fruits of that intellectual labor. To this end, the volume presents the results of a comparative study on intellectual property and access to medicines in eleven Latin American countries: five from South America (Argentina, Brazil, Chile, Colombia, and Ecuador), and six from Central American (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua). Through detailed socio-legal studies of this region using a standardized analytical framework and methodology, the book delves into the legal, political, and economic processes that explain the commonalities and differences among laws and practices adopted from the early 1990s until the early 2010s, during a period when each country was undergoing massive institutional and legal transformation.
Second, we theorize as to how the differentials among countries occur and why they endure within a common transnational regulatory framework. Here, our analytical and methodological approach draws on theories of political opportunity structures articulated by international relations scholars and political sociologists, as well as on the socio-legal literature that has documented the role of transnational networks of lawyers and consultants, government officials, activists, and NGOs in constructing and contesting legal rules in the context of globalization.
Third, we examine the core thesis of the global administrative law movement, which equates the problem of legitimating national administrative action with the challenge to legitimate the complex regulatory environment developing at the international level. To commentators such as Kingsbury, Krisch, and Stewart (2005), procedural principles—such as rights to notice, access to documents, transparency, and participation; a requirement for reasoned decisions and a right to review—which were developed in national settings to constrain administrative action and make it accountable to the people, can serve equivalent aims internationally. By comparing the outcomes for access to medicine in these eleven countries, all with similar commitments to democracy and comparable opportunities for contestation, we consider the force of this thesis. In the process, we identify conditions that permit administrative norms to empower constituencies that might otherwise be disregarded and that thus enable procedural approaches to provide a functional approximation of democratic governance.
(p.4) Because this volume draws on diverse disciplines, we begin with an introduction to the discourse of global administrative law, to the theories of political contestation that underlie the analysis, to the concepts of intellectual property law relevant to the medicines debate, and to a history of the region. We end the chapter with an overview of the remainder of the book, including a description of the methodology employed and a summary of the studies (set out in Chapters 2–7) and the accompanying commentary (found in Chapters 8–13). In Chapter 14, we return with a discussion of the findings that emerge from the case studies.
Noting the explosive growth of international instruments, Benedict Kingsbury, Nico Krisch, and Richard Stewart (2005) launched the global administrative law research project to study an accompanying phenomenon, the upsurge in transnational regulatory activity. In their view, the rise in transnational regulation is a response to the cross-border movement of people, knowledge, and goods; to concerns such as pollution and climate change, which are indifferent to national boundaries; to actions, such as conspiracies to restrain trade, where activity in one country has spillover consequences in others; and to problems, such as labor standards, monetary policy, and national security, which nations best address cooperatively. Whereas international treaties and conventions provide the broad strokes for dealing with such issues, Kingsbury, Krisch, and Stewart (2005) focus on a range of regulatory approaches which have been developing to implement these instruments and to address more granular concerns.
In the case of formal multilateral agreements, the principal actors are international representatives of national governments or officers operating under the auspices of an international agreement or within the framework of an international institution (such as the WTO or the World Bank). However, much of the current regulatory activity is more informal and less hierarchical: decentralized administration by national actors or national administrators (for example, patent offices and antitrust agencies), private-public partnerships (including ICANN and the Codex Alimentarius Commission), or private parties (e.g. anti-doping sports organizations and standard-setting bodies). In some instances the parties’ actions are localized; in other cases, the actors form transnational networks that operate in concert. Under a variety of auspices and configurations, these international organizations, national governments, national regulators, courts, private organizations, TNCs, and NGOs are engaged in activities with an impact—often a direct impact—on states and individuals.
In part, the GAL project is intended to be descriptive: to develop a taxonomy of regulatory regimes, to learn more about the allocation of regulatory responsibility among the various systems, and to examine how they function. In large part, however, the goals are normative and prescriptive. These transnational systems developed organically and can be quite effective. But those that operate autonomously—independent of both states and international institutions—or (p.5) outside traditional hierarchies can lack legitimacy and accountability. To be sure, a normative critique of administrative action is hardly new; many nations delegate substantial power to domestic regulatory agencies in ways that raise similar concerns. But as Kingsbury, Krisch, and Stewart (2005) point out, within national systems, a body of administrative law had developed to constrain regulators and render them accountable. Procedural principles, such as rights to notice, access to documents, transparency, and participation; a requirement for reasoned decisions; and a right to review, set significant limits on what administrators can do and on how they may proceed. These norms give voice to those affected by the regulatory regime and alter the political economy, empowering constituencies that might otherwise be excluded or underrepresented. Kingsbury, Krisch, and Stewart (2005) suggest that similar mechanisms could operate effectively in the realm of global regulation.
At the heart of the GAL project (and this book) lies the question of whether—or more accurately, when—they are right. There are many reasons to be concerned that national approaches cannot be effectively transposed to the international context. First, the global administrative norms thus far identified represent the values of a specific set of countries, largely in the global North. They do not derive from international instruments, nor can they be considered general principles on which all nations have converged. Thus, these norms have a legitimacy problem of their own. Other countries may not accept them. Indeed, the administrative law of the North may be viewed elsewhere as simply another form of imperialism: as a system of accountability to the North, as empowering the North at the expense of the South; as disruptive of other approaches to social ordering or as undermining other, equally valid, concepts of legitimate governance.
Second, in many transnational administrative settings there is no judiciary to review decisions or impose procedural mandates. Informal regulations may not be framed as binding rules suitable for review. Private actors do not ordinarily owe cognizable duties to a higher (national or international) authority. Thus, as Eyal Benvenisti (2005) suggested, administrative values may be driven mainly by a desire by administrative bodies to appear legitimate. But that requires administrators to see their reputations as on the line and to believe that the advantages of a good reputation outweigh the benefits that can be obtained by responding to political pressure, by self-dealing, or through more active forms of corruption. In some cases, the problem may be deeper: since the actions of networks cannot always be attributed to any single actor, there may be no one shouldering the responsibility to act in accordance with procedural norms.
As Martin Shapiro (2005) pointed out, administrative law is also something of a cat-and-mouse game. An agency bent on adopting its own approach will find ways around administrative constraints. The law might catch up, but only for a time. The more technical the issues, the worse the potential outcome. Expert decisions on technologically complicated matters can be difficult for lay reviewers to consider. When the technocrats’ solutions are so complex they are not as a practical matter reviewable, regulators can readily displace the public interest with their own. At the same time, if a field is technologically complex and the regulators or those reviewing (p.6) their actions have too little expertise, or the wrong kind of expertise, they can equally easily (but perhaps less intentionally) undermine important social values (Büthe and Mattli 2011).
Further, capacity deficits or asymmetries may make the availability of procedural opportunities ineffective, no matter how well fortified by GAL norms. It is expensive to field international delegations of negotiators. Legal and economic advisors may not be positioned to fully discern the consequences of a proposed rule; diplomats new to the international stage may be unable to build alliances to press their nation’s interests. Furthermore, richer countries have bargaining chips that permit them to isolate effective negotiators and split potential allies (Drahos 1995; Sell 2003). And for the rich, no loss is permanent. They can impose new costs by shifting their demands to a different regime (Helfer 2004). Worn down by repeated negotiations in far flung locations, poorer states ultimately succumb. These countries then face political, informational, and logistical obstacles as they are forced to compromise local interests in order to meet obligations poorly tailored to their circumstances.
Some transnational governance systems include international tribunals that are themselves cabined by GAL norms. But even here, a state with limited capacity may be disadvantaged. Defending its actions (let alone mounting a challenge) is costly and requires skilled lawyering. A country unwilling to risk the possibility of dispute resolution may be forced to enact laws that are beyond reproach—but which have local consequences that are far more severe than the international instrument, in fact, requires. If countries with equivalent concerns are similarly hampered, the international tribunal may be unable to generate sufficient law to provide adequate guidance on compliance matters (Dinwoodie and Dreyfuss 2012).
Admittedly, administrative law also includes a set of substantive standards—Kingsbury, Krisch, and Stewart (2005) mention requirements of proportionality, preservation of legitimate expectations, use of the least (or less) restrictive-means, along with testing for means-end rationality. But these doctrines beg the question: which expectations are legitimate? Against what metric are means and ends tested? Deeper substantive content—such as conceptions of fairness, of distributive justice, of human rights, of finality and repose—would appear to be required, but they are not, strictly speaking, a part of the administrative law enterprise.
These concerns make the descriptive exercise all the more important. While no one study can consider all these issues, an examination of global administration in diverse substantive areas and across a spectrum of countries, can reveal the problems with relying on global administrative values to achieve legitimacy. With a contextual approach, it is possible to illuminate the social and legal conditions necessary for operationalizing global administrative norms. As shown by the subsequent chapters in this volume, case studies can provide clues for adjusting the principles to particularized needs and suggest other stratagems for legitimating the imposition of transnational regulation on individuals and states.
In the final analysis, however, the power of administrative norms is heavily dependent on political opportunities for contestation and the capacity of those affected by regulation to contest effectively. Thus, the analytical framework and (p.7) empirical evidence presented in the chapters of this book foreground the role and effects of contestation in transnational regulation. This task calls for additional conceptual and methodological tools, to which we now turn.
According to Lustig and Kingsbury (2006: 413), “[p]rocedural approaches drawing on administrative law principles can act as an instrument of resistance and change.” As Lustig and Kingsbury’s work illustrates, the Global Administrative Law framework has tended to focus on whether the use of existing rules can give leverage to subaltern actors resisting injustices and seeking social change.4 But as suggested above, these rules may not be sufficient to confer legitimacy everywhere. Accordingly, in this book, we supplement the GAL focus with an analysis of the production of new rules. By inquiring into this genealogical moment, we show that the very content of procedural rules results from contestation among national and transnational actors advancing contrasting political and legal agendas. For instance, while some central actors in the transnational regulation of intellectual property—for example, the WTO, TNCs in the pharmaceutical sector, OECD governments (at times in conjunction with some governments in the global South), lawyers, and other technical and legal experts—have advocated greater protection of intellectual property rights in the global economy, other key actors—WHO, national and transnational human rights NGOs, some Southern governments (notably India, South Africa, and Brazil), firms producing generic drugs, also accompanied by lawyers and experts—have advanced an agenda that seeks to limit intellectual property rights in order to facilitate access to essential medicines (Kapczynski 2008; Klug 2005).
Procedural rules, therefore, embody provisional equilibria within legal regimes and reveal the correlation of forces among contending actors promoting alternative conceptions and standards of procedural fairness. Further, both in theory and in practice, the application of procedural questions cannot be entirely separated from substantive and distributional questions as to who benefits from a particular rule (Chimni 2005; Lustig and Kingsbury 2006). We argue that the political nature and substantive connotations of procedural rules can be seen with particular clarity at critical historical junctures when such rules are produced or transformed, for the new rules draw the line between competing claims of procedural and substantive justice and choose from alternative legal standards.
To this end, the studies in this volume draw on theories and methods from two lines of social science and socio-legal research on global governance. First is the growing literature on transnationalism and transnational networks, which complements the structural analysis that accompanies theories of political opportunities. (p.8) The focus of this literature is on formal and informal networks of global and local experts, advisors, scholars, and activists through which rules are circulated (and contested), at both official negotiations (for instance, negotiations within the context of FTAs) and in unofficial venues (such as at WIPO workshops, and professional meetings) (Slaughter 2004). Taking a cue from the literature on epistemic communities (Hall 1993) and the globalization of legal cultures and expertise (Dezalay and Garth 2002a), particular attention is given to the diffusion of ideas and normative frameworks through networks of patent and trade lawyers, public-health experts, human rights advocates, and other transnational actors (Halliday 2009). Borrowing from socio-legal studies on bottom-up construction and contestation of legal rules (Santos and Rodríguez-Garavito 2005), contributors also consider activist networks, which have proliferated in the last decade to advocate for more relaxed standards of protection in the name of promoting access to essential medicines.
Second, is the international relations and transnational social movement literature, which considers what political scientists and political sociologists have termed “political opportunity structures,” that is, “consistent—but not necessarily formal or permanent—dimensions of the political environment that provide incentives [and constraints] for collective action by affecting people’s expectations of success and failure” (Tarrow 1998: 77). Importantly, international relations scholars have expanded this concept to include not only domestic political opportunities, but also those associated with international institutions and actors. Drawing to various degrees on the tradition of two-level game theories of the interaction of international and domestic political structures (Evans, Jacobson and Putnam 1993; Putnam 1988), international relations scholars have sought to develop interactive explanatory models of a wide range of political processes, from the development of trade policy to the use of force in conflict resolution (Milner and Rosendorff 1997).
Loosening the game-theoretical assumptions of the original model, social movement scholars within the subfield of international relations have theorized and documented the ways in which two-level governance structures shape and are shaped by cross-border activist networks and coalitions (Khagram, Riker, and Sikkink 2002; Keck and Sikkink 1998). They have shown that opportunities for contestation at the local level are profoundly influenced by transnational institutions (for instance, the WTO, the International Monetary Fund (IMF), and the World Bank), as well as by national institutions in other countries (for instance, trade-promotion agencies in the North, such as the office of the United States Trade Representative (USTR)). In their view, the incentives for contestation stemming from national institutions may point in the opposite direction from those emanating from supra-national institutions. In the concluding chapter and the case study on Colombia, we specifically draw on Kathryn Sikkink’s “dynamic multilevel governance” approach, which offers an interactive theory of transnational mobilization (Sikkink 2005a, 2005b).
In sum, while the analysis of political opportunities allows us to study structural constraints, the literatures on transnationalism and bottom-up transnational mobilization gives us leverage on the role of actors and networks in exploiting and (p.9) shaping those constraints. The detailed accounts in the case studies specify the mechanisms through which structures shape (and are shaped by) actors’ strategies. Further, it shows how they develop institutions and norms appropriate to their own circumstances.
For many reasons, intellectual property furnishes an excellent context in which to analyze the dynamics of transnational regulation. To begin, this is an area in which the need for global governance is acute. As noted at the outset, exclusive rights in knowledge goods are quintessentially territorial: the right to exclude others from using an invention, a writing, or a mark, depends solely on the law of the country where the information is used. Without multilateral agreements, creators in one country would not be eligible for protection in foreign markets. In those territories, innovators would be unable to maintain the value of their marks or the reputation of their products or secure a return on their investments. Furthermore, each country could undermine the innovation policy of all others. Especially with the advent of the internet and digitization, cheap reproductions and imitations (or knowledge about making them) can easily spread, undercutting prices worldwide, including in the creator’s own market, and thus reduce incentives to innovate.
In addition to a complicated environment, in which regulatory competition could play either a positive role in the evolution of legal norms or lead to inconsistency, conflict, and illegitimacy (Cassese 2005a), the intellectual property regime has several other features that make it an interesting arena in which to study transnational governance and global administrative law. The stakes are extremely high. International regulation of knowledge products can have a significant impact on individuals. Trademark protection, especially the requirement for protecting well-known marks, gives out-of-state competitors a leg up on exploiting new markets (Leaffer 1998). Copyright protection raises the costs of educational materials, making it harder for people to acquire the training necessary to compete in a knowledge-based economy where sophisticated skill sets are often required (Chon 2006). Most pertinent for this study, patents, trade secrecy, and data exclusivity laws can raise the cost of medicine, medical procedures, and medical devices. Ironically for the global South, they do so without creating incentives to invent products that treat conditions, such as dengue fever, river blindness, or malaria, that uniquely afflict those who live in nonmarket economies (Wong and Dutfield 2011).
Intellectual property is also technically abstruse and applies to products that can be technologically complex. Thus, it is an area where Shapiro’s concerns about technocratic administration are at their zenith (Shapiro 2005). For example, disputes over intellectual property and access to medicines can require specialized knowledge about chemical components and products, cost-benefit analysis, financial risk assessment, and the economics of generic competition. The values that traditionally undergird information law can easily be lost in the analysis (Sell 2003; Keating 2005; Dinwoodie and Dreyfuss 2012). Technical complexity can also accentuate capacity and resource problems. Many of the issues in intellectual property law are empirical in nature: without data on the effect of patents on the price and profitability of pharmaceuticals, and without medical information on the interchangeability of the drugs on the market, it is difficult to know when intellectual property protection is necessary to promote innovation and when it (p.14) will mainly impede access to medication or impair health. Much of the law is also extremely arcane. Countries that previously lacked patent protection for pharmaceuticals may, for instance, have great difficulty understanding the choices available in fulfilling their duties to protect undisclosed data or lack a nuanced grasp of the ways in which the inventive-step requirement in patent law can be implemented.
Finally, intellectual property is a fruitful area in which to investigate transnational legal production and administration because it furnishes an occasion to conduct a natural experiment. Even with all the recent regulatory activity, the international regime sets only baseline protection. Accordingly, control over the exploitation of knowledge products in a particular place depends, at the end of the day, on both the quality of the contestation opportunities presented (including the degree to which each adheres to global administrative norms) and the capacity of each country to fully utilize them and generate norms of their own. As the case studies show, these opportunities can be divided into three stages.
Formally, both organizations offer procedural safeguards. WIPO, for example, holds itself out as open to the participation of industry groups, NGOs, the WTO, as well as other international organizations and stakeholders (Okediji 2008). WTO negotiations are somewhat more opaque (Esty 2006), but the Council is open to all members and permits observers (Dreyfuss 2009). The DSB follows the quasi-judicial procedures set out in the DSU and has added more procedural principles through interpretation (Cassese 2005b).31 Indeed, both organizations have been responsive to the South. For instance, they have clarified the scope of exceptions (p.15) and limitations32 and modified the compulsory license provision.33 However, a comparative study of the success of individual nations provides an opportunity to gauge the extent to which local capacity problems can diminish the ability of countries to fully utilize these openings to craft international law responsive to their needs and values.
The second opportunity for contestation comes at the implementation stage. Parts of the Paris and Berne Conventions may be self-executing, at least in some countries (Ladas 1975). For the most part, however, international intellectual property instruments contemplate implementation by each member state into domestic law. To be sure, there is less flexibility at this stage: one reason that participation at the international level is important is because the agreements cabin the choices states can make. But the TRIPS Agreement—even when augmented by bilaterals—still leaves room to maneuver. Here, a comparative study can identify the factors that affect the ability of nations to use these flexibilities to shape law that balances access needs against the interest in using intellectual property law to promote innovation.
For patents and trade secrets, the third opportunity for contestation arises at the application stage, in connection with the examination of patents and the administration of data exclusivity laws by regulatory agencies (and later, by courts). In terms of impact on individuals this is where the rubber meets the road. For example, it is ultimately the patent office that determines whether a particular medicine will be sold at a supracompetitive price or whether generic competition will improve availability. Once again, what happened at the international level penetrates the local, but it is the capacity, resources, and procedural opportunities at these agencies that ultimately operationalize the balance the regulatory regime has struck (Kapczynski 2009; Drahos 2009).
Most important, TRIPS does not define key terms. For medicines, the absence of definitions for new and inventive step provides a great deal of leeway. Thus, while many countries award patents for new uses of known compounds (that is, patents on the process for using a known compound to treat a new disease), some countries regard such second-use patents as invalid on the ground that they attempt to protect inventions that are not sufficiently novel (new) or inventive. By the same token, there are national differences as to whether patents will be granted on minor variations of known chemicals (for example, a new salt of a known active ingredient). TRIPS’s requirement for pipeline protection is similarly flexible. At one time, the United States claimed that countries in transition must immediately grant patents on inventions patented elsewhere, but the Appellate Body rejected that contention.51 As a result, countries in transition must register patent applications during the transition period, but they can delay protection until after the transition period has elapsed. More important, they may apply their own law to these patents. Thus, a country that does not recognize second-use patents can reject a patent on a new use even though another country (such as the United States) awarded a patent on that advance.
Other flexibilities are also available. The TRIPS Agreement takes no position on parallel importation (other than to require national and most favoured nation treatment).52 Thus, a country may consider the authorized sale of a patented product in another country to “internationally exhaust” the patent holder’s interest, allowing the product to be imported and sold locally without permission. These international exhaustion rules permit countries where the price of medicine is high to obtain supplies from countries where the prices are lower.
Prior to the TRIPS Agreement, several countries refused to award patents to pharmaceutical products (although some awarded them to processes for manufacturing pharmaceuticals). As a result, many established strong generic drug industries, which developed considerable expertise in methods for manufacturing unpatented pharmaceutical products cheaply. Some generic companies compete solely on price; others—branded generics—develop strong reputations for quality and valuable trademarks.53 They can sell these branded drugs at higher prices, but the cost is usually below the price that could be demanded by a proprietary firm for (p.18) a patented product. Furthermore, some countries require that generic manufacturers prove that each generic product is as biologically available in the body as the stated equivalent proprietary drug. In some countries, however, such proof of bioequivalence is not required, or required only of high-risk medicines. When it is not, copies may be called by another name (similars, for example).
While product patents are now required by reason of the non-discrimination provision, several of the flexibilities in TRIPS protect the viability of this important industry. There is no requirement that existing process patents be converted into product patents. Further, as a Panel of the WTO Dispute Resolution Body recognized, the general exceptions provision permits countries to adopt a so-called Bolar (regulatory review) exception.54 The Bolar exception allows generic drug companies to use the patent period to compare their drugs to the patented product, prove bioequivalence, and thus prepare to enter the market as soon as the patent expires.
The generics industry is also affected by the data exclusivity provision of the TRIPS Agreement, which protects information generated (often at high cost) in order to obtain pre-market clearance from agencies that monitor safety and efficacy.55 The provision refers to protection against “unfair commercial use” and applies to data on “new chemical entities” obtained with “considerable effort,” but (as with the patent provisions) none of these terms is defined. Countries are thus free to decide whether the right to invoke this protection requires the invention of a new active ingredient or simply adaptation of a known ingredient to create a new product (for example, by tableting the active ingredient differently). Each nation can also determine the period of data exclusivity for itself, and decide whether the period begins when the data is submitted for the first time anywhere in the world or when it is submitted locally. Arguably, TRIPS would also permit countries to refuse to accord exclusivity to data that was initially generated for review in another country and thus requires no additional local effort.
Finally, even though TRIPS contemplates that pharmaceutical products will be scrutinized for safety and efficacy, it does not require term extension to compensate for delays in this process (or, for that matter for delays in patent examination), even when countries adopt a Bolar exemption that permits use of the patented invention by generics during the patent term. Nor does TRIPS require linkage between patenting and market clearance determinations by the agencies that protect safety and efficacy. Some linkage between the efforts of a patent office and the agency regulating drugs may be desirable. For example, in the United States, a generic company must notify the Food and Drug Administration when it is seeking to market a patented drug and the law deems the expression of that intention to constitute a technical infringement. This creates a justiciable controversy and allows the generic manufacturer to test patent validity and thus determine its freedom to (p.19) operate prior to investing in efforts to copy and commercialize the drug. The US scheme also provides patent holders with a degree of protection and the generic with an incentive to challenge the patent.56 However, nothing in TRIPS mandates this regime, nor does the Agreement require the regulatory agency that determines safety, efficacy, and bioequivalence to enforce patents or to refuse to clear generic drugs for marketing because they would be infringing if sold.
Because the standards established by TRIPS are minimal, WTO members also enjoy flexibility to “implement in their law more extensive protection than is required by [the] Agreement.”57 As noted earlier, there are regional and bilateral agreements, as well as unilateral actions, which demand revision upwards. Our studies turn on the fact that some nations have withstood these pressures better than others.
Because we start from the premise that the impact of procedural rules can be observed with particular clarity at critical historical junctures—at times when new lines are drawn between claims and choices must be made among alternative legal standards—we take the early 1990s as the starting point for our study of Latin America. The onset of global neoliberalism and the knowledge economy, which undergirded the rise of the transnational regulation of intellectual property at that time, had an important echo within Latin America. In the mid-twentieth century, the Economic Commission for Latin America and the Caribbean (ECLAC) and other governments throughout the region had embraced an import substitution industrialization (ISI) model of development. Centered on a proactive state entrusted with the task of promoting national industry, the ISI approach restricted imports and established mechanisms to promote the growth of domestic industries. For intellectual property, the ISI model aimed to foster local pharmaceutical production. Most important for pharmaceutical TNCs, the Andean Community’s Decision 85 of 1974 prohibited patents on certain products, including medicaments and therapeutically active substances. With these products unprotected, a local generic industry could flourish.
But this approach was not to endure. A few years after Decision 85 was adopted and as the so-called “debt crisis” hit Mexico in 1982 and spread throughout the region, the ISI model became discredited in both academic and policy circles. Unable to sustain the budget deficits accumulated during the ISI years and prompted by the IMF and the World Bank, the countries of the region liberalized their economies and adopted the set of policies that would become known as the “Washington Consensus.” According to Williamson’s canonical formulation (p.20) (1990), the Washington Consensus programs promoted by the World Bank and the IMF typically included ten key policy reforms: fiscal discipline, public expenditure reduction and reorientation, tax reform to broaden the tax base, financial liberalization, competitive exchange rates, tariff reduction, elimination of barriers to foreign direct investment, privatization of state-owned enterprises, promotion of market competition, and provision of secure property rights (including intellectual property rights).
The transformation of intellectual property law was an integral part of these market-oriented, neoliberal reforms. The reforms in this area were most visible in those countries that adopted the “shock therapy” version of the Consensus. The iconic case was that of Chile, which established patents over pharmaceutical products through Law 18.935 of 1989, during the last year of the Augusto Pinochet dictatorship. A similarly orthodox attempt at neoliberal reform was undertaken by the governments of Carlos Menem in Argentina. It included repeated (and ultimately unsuccessful) efforts to convince Congress to pass aggressively pro-intellectual property legislation between 1989 and 1995.
Growing evidence of the failure of structural adjustment led neoliberal advocates (including Williamson himself) to call for a second wave of structural reforms, this time centered on institution building (Naím 1994; Williamson 2003). The global turning point was the Asian crisis of 1997, which proved that critics who had warned against the perils of rapid and unconditional deregulation of the economies of the global South were correct. In response and to avert further crises, promoters of the Washington Consensus advocated the establishment of a regulatory regime capable of overseeing the operation of liberalized markets. The outcome was an even broader reform agenda. To the original ten-point list, a wide range of loosely connected and vaguely formulated reforms were added. Among them were the “flexibilization” of labor laws, the establishment of financial regulations and standards, the revamping of market oversight agencies, and the implementation of targeted social policies (Navia and Velasco 2003). Importantly for our purposes, the institutions targeted for reform included national patent offices. Throughout Latin America, national governments came under heavy and increasing international pressure—mainly through the periodic reports and threats of unilateral sanctions by the USTR’s Special 301 mechanism—to streamline patent-granting procedures and agencies, so as to swiftly and efficiently protect the rights of patent applicants and holders.
A considerable number of Latin American countries have also gone through a third phase of neoliberal reforms. These were required to implement the provisions of multilateral FTAs (CAFTA and the North American Free Trade Agreement, NAFTA) or bilateral FTAs (such as those signed by Colombia, Peru, and Chile with the United States, Canada, and the European Union). As the case studies on Central America, Colombia, and Chile show, the FTAs have often been the conduit through which TRIPS-plus standards have been incorporated into national legislation. Illustrations include FTA clauses requiring states to further streamline patent-granting procedures for pharmaceuticals by establishing an administrative linkage between the national agency responsible for reviewing applications for (p.21) patents and the agency in charge of reviewing the drug’s safety and effectiveness. Important exceptions to this ongoing wave of reforms are those countries in which left-leaning governments have shied away from FTAs and strengthened the role of the state in the regulation of the economy. To varying degrees and with different connotations, Brazil, Argentina, and Ecuador illustrate this trajectory in our sample.
However, neoliberalism has not been the only influential project of institutional reform in the region at the turn of the century. Overlapping in time with the Washington Consensus—but defending a markedly different vision of regulation and human rights—new constitutions and constitutional reforms throughout the region incorporated generous bills of rights and judicial review mechanisms (Rodríguez-Garavito 2011a). The 1988 Brazilian constitution inaugurated a regional wave which many others joined, including Colombia (1991), Peru (1993), Argentina (1994), Mexico (1994), Venezuela (1998), and, more recently, Ecuador (2008) and Bolivia (2009). Importantly, constitutions, institutional reforms, and activist courts embodying this type of “neoconstitutionalism” are centrally concerned with socio-economic rights, including the right to health (Rodríguez-Garavito 2011b). By explicitly incorporating the international law on socio-economic rights into national constitutions and court decisions, the neoconstitutional project has provided human rights advocates with enforceable legal tools to contest regulations, including patent laws and patent rights, that limit access to affordable healthcare. The result has been a veritable explosion of court cases on the right to health, which have become by far the most litigated issue in constitutional jurisdictions across the region (Yamin and Gloppen 2011).
The tangible consequences of the global intellectual property regime on access to medicines are felt at the domestic level. In order to capture the operation and variation of rules on the ground, these case studies focus on Latin America during the period when the profound political, economic, and legal transformation described above occurred. This section begins with a description of the methodology employed in the studies. It then provides an overview of the studies as well as a series of comments solicited from other students of the region and human rights scholars.
This volume encompasses individual case studies of five South American countries, Argentina, Brazil, Chile, Colombia, and Ecuador, and a composite examination of six countries in Central America, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua. The studies were conducted by scholars at institutions affiliated with the Global Administrative Law network and coordinated through the University of the Andes. Given that the project’s overall objective was to tease out the reasons behind national differences, we selected countries that were hypothesized to vary on the dependent variable of interest: the strength of intellectual property rights implicated in accessing medicine. The countries all had similar commitments to democratic governance. However, we chose nations that differ on a host of explanatory variables associated with our analytical point of departure: national, regional, and international institutional structures; participation in relevant national and international networks of experts and activists; size of the local generic industry; participation in FTAs; economic and geopolitical clout; strength and impact of civil society mobilization; and recognition of human rights, including the right to health.
Drawing on a common research protocol, the case studies have three objectives. First, they offer an analysis of the general trajectory of the law and politics of balancing intellectual property interests and access to medicines in their respective country from the early 1990s until the early 2010s. Second, they empirically document the actual operation of institutions involved in the enforcement of intellectual property rights and access-to-medicines legal standards. Thus, while the first goal relates the evolution of “law on the books,” the second considers the trajectory of “law in action.” Third, the case studies present detailed accounts of key episodes in that trajectory, including activists’ campaigns, legislative battles, national litigation, and international negotiations and legal disputes.
To attain those goals, participants in the project used a combination of socio-legal research methods. The starting point consisted of a thorough examination of the relevant national laws and international treaties for each country, as well as the (p.23) rulings and proceedings from pertinent court cases. The second phase entailed systematic archival research, which included both physical archives (at relevant government agencies, industry associations, and NGOs) and online archives (e.g., of transnational civil society organizations involved in campaigns and fact-finding missions in the countries under study). Finally, the researchers conducted semi-structured interviews with government officials, NGO activists, intellectual property lawyers, human rights lawyers, representatives of transnational pharmaceutical companies and local generics producers, leaders of patients’ associations, agents of intergovernmental organizations (e.g., WHO), and local academics. Contributors carried out an average of thirty interviews in each country.
Argentina (Chapter 2). Paola Bergallo and Agustina Ramón’s study shows that the Argentine story has been one of a protracted, intense, and highly visible struggle over the regulation of patents on pharmaceutical products. The authors examine the twists and turns of this story during two periods. The first one, from 1989 to 1995, overlapped with the “shock-therapy” version of the Menem government’s neoliberal economic policies, which included an aggressive, sustained effort by the Ministry of the Economy to please the United States (and the USTR) by enacting a new intellectual property law that incorporated strong pharmaceutical patents. The reform drive encountered fierce resistance from the powerful national pharmaceutical industry, in alliance with influential sectors of Argentina’s Congress and certain agencies within the Executive branch, who managed to defeat Menem’s repeated attempts at legal reform.
The second period, from 1996 to 2010, revolved around the national implementation of TRIPS, as the United States and the international pharmaceutical industries increased pressure on the Argentine government, legislature, and courts to adopt a maximalist interpretation of intellectual property obligations under TRIPS. However, the same actors who successfully fended off efforts to ratchet up patent protection during the heyday of neoliberalism in the early 1990s largely succeeded in preserving and exploiting the flexibilities of TRIPS. The pro-access position received decisive political backing as the Menem legacy ended in the country’s economic collapse in 2001. New governments instead promoted regulations that created economic incentives for the use of generic drugs and adopted a proactive, pro-access stance in global forums such as WIPO and the WTO. Importantly, the authors conclude by showing that this outcome has not translated itself into lower drug prices, as national producers have profited from regulatory loopholes that allow them to set prices that are above those in similar countries, while passing on the additional charge to the healthcare system and—to some extent—to patients.
In sum, from a comparative perspective, the Argentine case is the clearest illustration in our sample of a relatively even and thus highly contentious and (p.24) protracted dispute over patent regulations. As evident in Table 1.1, the result has been a legal framework that, although compliant with the global TRIPS regime, makes allowance for virtually all of the flexibilities and exceptions that signal a pro-health commitment, while resisting TRIPS-plus standards. As we discuss in the concluding chapter, this outcome appears rooted in the political alliance between the domestic pharmaceutical sector and the long nationalist tradition of the Peronist party, which benefited from a wealth of local expertise. In a sense, Argentina achieved the best of both worlds: it complied with TRIPS, and it also assured access by funding medication for all Argentinians. At the same time, however, state support uses resources that could be deployed elsewhere. Furthermore, new relationships among local and foreign pharmaceutical companies and between pharmaceutical companies and insurance companies open opportunities for drug companies to charge outrageous prices and to receive kickbacks.
Brazil (Chapter 3). Mônica Rosina and Adelina de Oliveira Novaes’s chapter reconstructs the regulatory path Brazil followed as it transitioned from the “lost decade” of the 1980s into years of spectacular growth and effected the political transformation that launched the country into the status of emerging world power.
The Brazilian story is punctuated by the country’s incorporation of TRIPS obligations through Law No. 9279, which introduced patent protection and sacrificed several of the flexibilities allowed by TRIPS, among them the ten-year transition period. Tellingly, the law went beyond TRIPS by incorporating pipeline protection. The authors attribute the pro-intellectual property bent of this foundational legislation to the successful lobbying of transnational pharmaceutical corporations, in alliance with a sympathetic sector of the Brazilian Congress.
In reaction to this early trend, the 1990s saw the development of a vibrant coalition of civil society organizations at the national level, and the Brazilian left-leaning government, advocating at the international level for a more pro-health approach. Domestically, organizations such as ABIA, Conectas, and Doctors Without Borders, in alliance with the national industry, challenged pipeline protection before the courts and actively promoted the use of flexibilities such as the right of parallel importation. Although the law did not change, activists found a sympathetic ear in key sectors of the Cardoso and Lula governments—notably the ministries of health and international relations, which have been behind Brazil’s leading role in such pro-access initiatives as the Doha Round and the WIPO Development Agenda.
Although currently in flux due to ongoing legal challenges before domestic courts, the Brazilian story is paradoxical (the authors call it schizophrenic) in comparative perspective, for it combines strong patent protection at the legislative level with a decidedly pro-access stance at the implementation level, as shown by the government’s use of compulsory licensing and the Bolar exception. In part, the result can be explained by Brazil’s strong institutions—locally, a proactive health agency (ANVISA) and, internationally, negotiators able to create common cause with other emerging economies (including India, China, and South Africa) to bring development interests to the fore. In larger part, however, the outcome appears attributable to a strong government commitment to pay for healthcare.
(p.25) Central America (Chapter 4). Angelina Snodgrass Godoy’s chapter offers a comparative analysis of Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua, which highlights both the commonalities and the differences among these countries. On the one hand, they all went through the decisive regulatory change associated with the signing of CAFTA, which was ratified by the United States in 2005. Since the intellectual property standards in CAFTA are more demanding than those included in the FTAs that preceded it and in those that followed it, CAFTA is widely seen as the high-water mark of intellectual property protection. On the other hand, contrary to the customary treatment of Central American countries as a whole, the author shows how there have been important differences among them in the implementation and application of the CAFTA standards. These are reflected in Table 1.1.
The Central America story is the clearest illustration of a path of low resistance vis-à-vis proprietary interests. This path stems from both structural factors—especially the small size of domestic markets and the lack of geopolitical influence of countries in the region—and strategic factors—especially the fact that civil society organizations, weakened by the legacy of civil wars, were incapable of mounting a sustained counter-movement in defense of access to medicines. Indeed, the limited resistance that did occur was led and controlled by international NGOs. Snodgrass argues that the Central America trajectory offers a cautionary tale with regards to the more visible and hopeful stories of South American countries like Brazil and Argentina, whose size and geopolitical clout contrast with the realities of most countries in the global South.
Chile (Chapter 5). Salvador Millaleo’s account of the evolution of Chilean regulation of patents reveals the most linear, ostensibly pro-intellectual property story in our sample. Remarkably, its official stance favoring proprietary interests has remained steady since the failed attempt of the Pinochet dictatorship at regulating the issue before the transition to democracy in 1989. Indeed, the centrist coalition that ruled the country since the return of democracy in 1990 until 2010 (the Concertación) maintained the country’s commitment to global economic integration, and accepted increasingly strong intellectual property rules as part of the process, through three legislative steps.
First, Law No. 19.039 of 1991 introduced patents over pharmaceutical products. Second, No. 19.996 of 1996 (which entered into force belatedly, in 2005) increased standards of patent protection in compliance with TRIPS, which Chile had ratified in 1995. Finally, the signing of an FTA with the United States in 2003 entailed further obligations for Chile to expand patent protection (for instance, through the extension of patents beyond the twenty-year period to compensate for administrative delays), which the country honored through Law No. 20.160 of 2007.
Colombia (Chapter 6). César Rodríguez-Garavito’s study traces the Colombian regulatory path, from regional regulation at the Andean scale, to national legislation in response to pressure from the United States, to bilateral regulation as a result of the Colombia–US FTA. Due to Colombia’s commitment to Andean integration up to the 1990s, the introduction of patent protection and post-TRIPS expansion were the result of regulations at the Andean level (Decision 311 of 1991 and Decision 486 of 2000, respectively). However, Colombia gradually parted ways with its Andean neighbors and moved through a series of three political and legal processes toward a decidedly pro-patent orientation. First, its role as the key ally of the United States in the so-called “war on drugs” in the region and its position as the second-largest recipient of US military aid entailed a high exposure to unilateral pressures as embodied in Special 301 Reports. This led, for instance, to the government’s decision to yield to US demands to incorporate data protection into national legislation, which it did through Decree 2085 of 2002.
Second, Colombia stands out in our sample as the country with the most visible and protracted negotiation of intellectual property clauses in an FTA. Although negotiations of the FTA with the United States were inaugurated in May 2004 and scheduled to end with the ratification of the treaty in 2005, the FTA was eventually signed in 2006, but entered into force only in 2012. Although the general orientation of intellectual property clauses in the FTA is similar to that of the Chile FTA and CAFTA, the Colombia story is significant because the duration of the process allowed for the rise of a dynamic coalition of national and transnational pro-health organizations. In alliance with the domestic generic industry, this coalition effectively exploited international political opportunities (notably changes in the political majority in the US Congress in 2006) to prompt a renegotiation of the intellectual property provisions to avoid some of the most extreme concessions made by Chile and the CAFTA countries.
Third, as Colombia embarked on a wave of FTAs with the European Union, Canada, and countries around the world in the 2000s and 2010s, it consolidated its commitment to a pro-patent regulatory framework. This helps explain why, unlike other countries in our sample, it has largely skipped the use of TRIPS flexibilities and patent-related mechanisms to promote access to medicines. In the face of skyrocketing medicine prices, it has resorted instead to timid price-control measures. However, evidence of the negative impact of rigid patent protection and other regulatory failures has led the government to be more open to flexibilities in the implementation phase of the FTAs. High costs have also prompted activists and human rights lawyers to resort to courts to advance the pro-access cause.
(p.27) Ecuador (Chapter 7). Tatiana Andia’s chapter documents the zigzagging trajectory of this Andean country, which, like Colombia, followed the Andean turn towards a pro-intellectual property framework in the 1990s through the above-mentioned Decisions 311 and 486. In fact, Ecuador went beyond the Andean regulations by prematurely introducing pipeline protection through a bilateral agreement with the United States in 1993, which was incorporated into national legislation by Decree 1344-A. Like Brazil, its interests in access were ultimately defeated. But unlike Brazil, which has considerable clout of its own, Ecuador was saved by a strong regional institution—the Andean Tribunal of Justice.
Two factors make the Ecuadorean case unique within our sample. First, it joined TRIPS voluntarily in order to participate in a trade dispute over the importation of bananas into the EU. The challenge ended well for Ecuador when it threatened to retaliate against the EU by suspending obligations under the TRIPS Agreement.60 Its success created familiarity with both the WTO and intellectual property law. Second is Ecuador’s sharp turn in 2006 towards a pro-access, nationalist strategy under the Rafael Correa government. With political backing from a strong indigenous movement, along with a diverse coalition of human rights NGOs, and social justice organizations, the government sought to “insure universal access to essential medicines and consolidate the authority and sovereignty of the State in the use of medicine and phytotherapeutic resources,” as established by the Decree 118 of 2009. The Ecuadorean story thus offers rare evidence of the potential and the consequences of a small country’s decision to challenge the global intellectual property regime by maximizing the use of flexibilities and exceptions.
To facilitate a comparison among the case studies, Table 1.1 summarizes the results of the debates over intellectual property and access to medicines in the countries in our sample as of the end date of the studies. It thus offers a synthesized view of the outcome that concerns us: the degree to which national regulations protect proprietary and access interests. It lists eleven variables which affect access interest, framed so that YES designates a provision that is pro-access, while NO signifies a measure promoting proprietary interests. The variables include the availability of a diagnostic exception, a Bolar provision, or other health-related exemptions; the freedom to engage in parallel importation from countries with lower costs; the existence of compulsory licensing laws that can be used to compel working, to protect public health, or in favor of government use; whether the country has agreed to extend the patent term for delays in examination or market clearance; whether linkage is required; whether the country excludes the broadest possible protection for data (which is to say, protection for data on new products, as opposed to molecules) and second-use patents (which is to say, patents for second uses that represent only incremental change).
Does the country make an allowance for the following issues in its patent laws?
a General exception; not geared specifically to health issue.
b Agreed in FTA, but not implemented in domestic law.
d Agreed in FTA signed with the US (pending ratification in US Congress).
e Extension law does not apply to pharmaceuticals.
Part II of this volume supplements the case studies with comments by scholars versed in the underlying theoretical framework. Laurence Helfer, Karen Alter, and Amy Kapczynski have all conducted country studies using similar methodologies to our authors. Helfer and Alter (Chapter 9) contribute their perspective on the role of regional capacities—Andean law and the Andean Tribunal of Justice—in the balance that members of the Andean Community strike between health and innovation concerns. Kapczynski (Chapter 10) considers the next phase of the international intellectual property story: the impact of locally developed law on international norms, and the ways that one country’s experience can shape the contestation opportunities elsewhere.
Sean Flynn and Ruth Okediji take closer looks at how pressures build and are diffused at the international level. Our case studies show that the USTR’s Special 301 procedure plays an outsize role in implementation and application decisions; Sean Flynn (Chapter 8) considers how the Special 301 Reports have changed as contestation opportunities within the USTR have improved. The case studies also suggest that despite WIPO’s agreement to provide technical assistance on implementing TRIPS, the Organization is not perceived as helping countries strike the appropriate balance between proprietary interests and access to medicine. In her contribution, Ruth Okediji (Chapter 13) examines the role of WIPO. She explains why WIPO has, historically, not had a significant impact on the health debate. Starting from the proposition that greater linkage among the relevant international organizations would be desirable, she proposes an “action plan” for improving WIPO’s responsiveness to health concerns.
For many countries, success in adapting international obligations to local needs has turned heavily on national commitments to human rights and on the presence of human rights advocates, both foreign and domestic. Smita Narula (Chapter 12) (p.30) provides an overview of the rights-based approach to access to medicines, focusing on the work of international human rights bodies, mechanisms, and procedures. Molly Land (Chapter 11) takes a hard look at places where the human rights frame was unsuccessful, asking why it had so little traction in many of these countries and explores whether the developing A2K (access-to-medicines) frame will act as a stronger or weaker safeguard of access interests.
In the final chapter (Chapter 14), the authors suggest conclusions that can be drawn from the case studies and related commentary.
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(1) Berne Convention for the Protection of Literary and Artistic Works, July 24, 1971, 1161 U.N.T.S. 31 [hereinafter Berne Convention]; Paris Convention for the Protection of Industrial Property, July 14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 305 [hereinafter Paris Convention]. The Paris Convention also addressed the protection of other forms of industrial property, such as designs, utility models, and geographical indications. See Paris Convention, art. 1.2. See generally Ricketson and Ginsburg (2006); Ladas (1975).
(2) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round, Vol. 31, 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement].
(3) Understanding on Rules and Procedures Governing the Settlement of Disputes, April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, Legal Instruments—Results of the Uruguay Round, 33 I.L.M. 1125 (1994).
(4) Indeed, Lustig and Kingsbury themselves engage the issue of resistance within GAL in analyzing the impact of existing national and international legal rules on policies and debates regarding conservation-induced displacement and relocation of rural communities in India.
(5) Convention Establishing the World Intellectual Property Organization, July 14, 1967, 21 U.S.T. 1749, 848 U.N.T.S. 3.
(6) Berne Convention, art. 5; Paris Convention, art. 2.
(7) Paris Convention, art. 4 (requiring Union members to give priority to applications based on the first filing date in a Paris member; Ricketson and Ginsburg (2006: 341–56) (noting that Berne eventually made copyright automatic).
(8) For a full list of the instruments administered by WIPO, see <http://www.wipo.int/treaties/en/>. The recent agreements were concluded in 1996, see WIPO Copyright Treaty (WCT), December 20, 1996, 36 I.L.M. 76, 2186 U.N.T.S. 121; WIPO Performances and Phonograms Treaty (WPPT), December 20, 1996, 36 I.L.M. 76, 2186 U.N.T.S. 203.
(9) TRIPS, arts. 1.3, 3.1, 4(d), 63.2, 68, 71.
(10) Arts. 63 and 68 of TRIPS; Agreement between the World Intellectual Property Organization and the World Trade Organization, Preamble (22 December 1995), available at <http://www.wipo.int/treaties/en/agreement/pdf/trtdocs_wo030.pdf>.
(12) WTO/WIPO Agreement, arts. 4(1) and (3).
(13) See World Trade Organization, Ministerial Declaration of November 14, 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746 (2002) [hereinafter Doha Declaration]; Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2 (November 14, 2001)[hereinafter Declaration on Public Health].
(14) See, e.g., Proposal by Argentina and Brazil for the Establishment of a Development Agenda for WIPO, WO/GA/31/11 (August 27, 2004) (supported by, among other countries, Bolivia, Ecuador, and Venezuela). Documents on the Development Agenda are available at <http://www.wipo.int/ ip-development/en/agenda/>.
(15) World Intellectual Property Organization, Diplomatic Conference to Conclude a Treaty to Facilitate Access to Published Works by Visually Impaired Persons and Persons with Print Disabilities, VIP/DC, 8 (June 27, 2013).
(16) China—Measures Affecting the Protection and Enforcement of Intellectual Property Rights, WT/DS362/R (January 26, 2009).
(17) Anti-Counterfeiting Trade Agreement, May 2011 Text, available at <http://www.ustr.gov/acta>; the draft text of the Trans-Pacific Partnership Trade Agreement remain confidential, however information on negotiations through 2013 is available at <http://www.ustr.gov/tpp>; text of all free trade agreements involving the United States are available at <http://www.ustr.gov/trade-agreements/free-trade-agreements>.
(18) An example is the Dominican Republic—Central America—United States Free Trade Agreement (August 5, 2004) (CAFTA), available at <http://www.ustr.gov/trade-agreements/free-trade-agreements/cafta-dr-dominican-republic-central-america-fta/final-text>.
(19) 61 Omnibus Trade and Competitiveness Act of 1989, Pub. L. 100-418, 102 Stat. 1176–9 (1989); 19 U.S.C. § 2242. For examples of these Reports, see Office of the United States Trade Representative, Special 301 Reports, available at <http://search.usa.gov/search?sc=0&query=special+301+reports&affiliate=ustrgov&locale=en&m=>. The Special 301 procedure is examined in detail in Sean Flynn’s contribution to this volume, see Chapter 8.
(20) Council Regulation (EC) of December 22, 1994 No. 3286/94 Laying Down Community Procedures in the Field of the Common Commercial Policy in Order to Ensure the Exercise of the Community’s Rights under International Trade Rules, in Particular those Established under the Auspices of the World Trade Organization, 1994 O.J. (L 349) 71, as amended by Council Regulation (EC) No. 356/95 of February 20, 1995, 1995 O.J. (L 41) 3.
(21) World Health Organization, Department of Essential Drugs and Other Medicines, Counterfeit Drugs, Guidelines for the development of measures to combat counterfeit drugs, WHO/EDM/QSM/99.1 (1999).
(22) World Health Organization, Trade, Intellectual Property Rights and Access to Medicines (2010), available at <http://apps.who.int/medicinedocs/en/m/abstract/Js17521en/>. See also WHO, Report of the Commission on Intellectual Property Rights, Innovation and Public Health (2006), available at <http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf>.
(23) See, e.g., WHO Agenda, available at <http://www.who.int/about/agenda/en/index.html>.
(24) Universal Declaration of Human Rights, December 8, 1948, GA Res. 217A(III), UN Doc. A/810, at 71, art. 27(2); International Covenant on Economic, Social and Cultural Rights, adopted December 16, 1966, art. 15(1)(c), S. Exec. Doc. D, 95–2, at 13 (1997), 993 U.N.T.S. 3, 5 (entered into force January 3, 1976).
(25) UDHR, arts. 25 and 26; ICESCR arts. 10 and 12.
(26) UN Economic and Social Council, The Right to the Highest Attainable Standard of Health, E/C 12/2000/4 (August 11, 2000).
(27) UN General Assembly, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/63/263 (August 11, 2008).
(28) See, e.g, WIPO Model Provisions on Protection Against Unfair Competition, WIPO Publication No. 832 (Geneva, 1996), which defines the term “unfair competition” in art. 10bis of the Paris Convention.
(29) See, e.g., WIPO, Memorandum of the Director on the Joint Recommendation, WIPO Doc. A/34/13 para. 8 (August 4, 1999), available at <http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=1101>, which is referenced in various FTAs.
(30) See, e.g., World Trade Organization, Ministerial Declaration of November 14, 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746 (2002).
(31) An example is the decision to accept amicus briefs, see European Communities—Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/AB/R, paras. 50–7 (March 12, 2001); cf. United States—Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/AB/R, para. 110 (October 12, 1998).
(32) See, e.g., Standing Committee on Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights, SCP/15/3 Annex I (September 2, 2010) (prepared by Lionel Bently, Brad Sherman, et al.).
(33) See, e.g., TRIPS, art. 31bis.
(34) This section includes terms which may be used somewhat differently in each of the countries covered by this study. This background is meant to serve as a general glossary; when a term is defined differently in a particular study, the authors will highlight the difference.
(35) TRIPS, arts. 3 and 4.
(39) TRIPS, art. 65.1 and 2.
(43) TRIPS, art. 27.2 and 3(a).
(45) TRIPS, arts. 31 and 40.
(48) Ministerial Declaration and Declaration on the TRIPS Agreement and Public Health (n. 43); TRIPS, art. 31bis.
(49) Paris Convention, art. 5.
(50) Brazil—Measures Affecting Patent Protection, WTO Doc. WT/DS199/1G/L/385/IP/D/23 (June 8, 2000).
(51) India—Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (5 September, 1997).
(53) Terms associated with generic drugs are particularly likely to be utilized differently in the countries surveyed, see Homedes and Ugalde (2005).
(54) Canada—Patent Protection of Pharmaceutical Products, WT/DS114/R (17 March 2000). The provision takes its name from Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984), which led the US Congress to enact a regulatory review exception.
(56) 21 U.S.C. § 355 (known as the Hatch–Waxman Act); Rius Sanjuan (2006).
(58) Corte Suprema de Justicia de la Nación (Supreme Court of Argentina), JA-2001-I-413, October 24, 2000.
(59) In this way, Chile is not dissimilar from the United States. The United States’ demands for strong protection abroad stand in contrast to its domestic laws, which often balance proprietary and access interests in subtle but effective ways. The US version of linkage, recounted above, is an example.
(60) Decision by the Arbitrators, European Communities—Regime for the Importation, Sale and Distribution of Bananas—Recourse to Arbitration by the European Communities Under Article 22.6 of the DSU, para. 152, WT/DS27/ARB/ECU (March 24, 2000).
(61) For instance, outcomes such as administrative linkage and patent extensions to compensate for delays are mandatory for Central American countries under CAFTA (which are thus assigned a “No” in the Table), but have been rejected by other countries like Argentina and Ecuador (a “Yes” in the Table). However, a third regulatory option has obtained under other FTAs (such as the one signed by Colombia and the United States), which include provisions on linkage and patent extensions but make their enforcement optional (rather than mandatory), and thus leaves open these questions for further rounds of engagement between the parties as the implementation of the treaty unfolds. Since it is probable that the United States will exert heavy pressure to enforce those provisions during the implementation phase, we assign a “No” to Colombia under these two variables, while being aware that the binary format of the answer misses the fact that this intermediate alternative is not identical to the CAFTA requirements.

References: v. 
 art. 1
 art. 5
 art. 2
 art. 4
 § 2242
 art. 27
 art. 15
 art. 10
 art. 31
 art. 65
 art. 27
 art. 31
 art. 5
 v. 
 § 355